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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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Welch Allyn, Inc. - 00732094269574

ELI230 12-Lead Multi-Channel Electrocardiograph -Color LCD display, AC or battery operation with WAM Wireless Acquisition Module (includes 1 starter roll paper - Thermal Roll appx 50 ft.); current software; Australia power cord; AHA 10 wire, 12-lead lead set with banana plugs; Adult and pediatric interpretation; No accessories; ; ;
WELCH ALLYN, INC.
901130
In Commercial Distribution

  • 00732094269574 ()
ELI230-ABA-ADXXX

  • Electrocardiograph, professional, multichannel

Welch Allyn, Inc. - 00732094269543

ELI230 12-Lead Multi-Channel Electrocardiograph -Color LCD display, AC or battery operation with WAM Wireless Acquisition Module (includes 1 starter roll paper - Thermal Roll appx 50 ft.); current software; Australia power cord; AHA 10 wire, 12-lead lead set with banana plugs; Adult and pediatric interpretation; No accessories; ; ;
WELCH ALLYN, INC.
901130
In Commercial Distribution

  • 00732094269543 ()
ELI230-ABC-ADXXX

  • Electrocardiograph, professional, multichannel

Welch Allyn, Inc. - 00732094269444

ELI230 12-Lead Multi-Channel Electrocardiograph -Color LCD display, AC or battery operation with WAM Wireless Acquisition Module (includes 1 starter roll paper - Thermal Roll appx 50 ft.); current software; UK power cord; IEC 10 wire, 12-lead lead set with banana plugs; Adult and pediatric interpretation; No accessories; ; ;
WELCH ALLYN, INC.
901130
In Commercial Distribution

  • 00732094269444 ()
ELI230-ACB-ADXXX

  • Electrocardiograph, professional, multichannel

Welch Allyn, Inc. - 00732094269413

ELI230 12-Lead Multi-Channel Electrocardiograph -Color LCD display, AC or battery operation with WAM Wireless Acquisition Module (includes 1 starter roll paper - Thermal Roll appx 50 ft.); current software; UK power cord; AHA 10 wire, 12-lead lead set with banana plugs; Adult and pediatric interpretation; No accessories; ; ;
WELCH ALLYN, INC.
901130
In Commercial Distribution

  • 00732094269413 ()
ELI230-ACC-ADXXX

  • Electrocardiograph, professional, multichannel

Welch Allyn, Inc. - 00732094269376

ELI230 12-Lead Multi-Channel Electrocardiograph -Color LCD display, AC or battery operation with WAM Wireless Acquisition Module (includes 1 starter roll paper - Thermal Roll appx 50 ft.); current software; UK power cord; IEC 10 wire, 12-lead lead set with banana plugs; Adult and pediatric interpretation; No accessories; ; ;
WELCH ALLYN, INC.
901130
In Commercial Distribution

  • 00732094269376 ()
ELI230-ACD-ADXXX

  • Electrocardiograph, professional, multichannel

Welch Allyn, Inc. - 00732094269352

ELI230 12-Lead Multi-Channel Electrocardiograph -Color LCD display, AC or battery operation with WAM Wireless Acquisition Module (includes 1 starter roll paper - Thermal Roll appx 50 ft.); current software; UK power cord; IEC 10 wire, 12-lead lead set with medi-clip ends; Adult and pediatric interpretation; No accessories; ; ;
WELCH ALLYN, INC.
901130
In Commercial Distribution

  • 00732094269352 ()
ELI230-ACF-ADXXX

  • Electrocardiograph, professional, multichannel

Welch Allyn, Inc. - 00732094269314

ELI230 12-Lead Multi-Channel Electrocardiograph -Color LCD display, AC or battery operation with WAM Wireless Acquisition Module (includes 1 starter roll paper - Thermal Roll appx 50 ft.); current software; International power cord; AHA 10 wire, 12-lead lead set with banana plugs; Adult and pediatric interpretation; No accessories; ; ;
WELCH ALLYN, INC.
901130
In Commercial Distribution

  • 00732094269314 ()
ELI230-ADA-ADXXX

  • Electrocardiograph, professional, multichannel

Welch Allyn, Inc. - 00732094269253

ELI230 12-Lead Multi-Channel Electrocardiograph -Color LCD display, AC or battery operation with WAM Wireless Acquisition Module (includes 1 starter roll paper - Thermal Roll appx 50 ft.); current software; International power cord; IEC 10 wire, 12-lead lead set with banana plugs; Adult and pediatric interpretation; No accessories; ; ;
WELCH ALLYN, INC.
901130
In Commercial Distribution

  • 00732094269253 ()
ELI230-ADB-ADXXX

  • Electrocardiograph, professional, multichannel

Welch Allyn, Inc. - 00732094269246

ELI230 12-Lead Multi-Channel Electrocardiograph -Color LCD display, AC or battery operation with WAM Wireless Acquisition Module (includes 1 starter roll paper - Thermal Roll appx 50 ft.); current software; International power cord; AHA 10 wire, 12-lead lead set with banana plugs; Adult and pediatric interpretation; No accessories; ; ;
WELCH ALLYN, INC.
901130
In Commercial Distribution

  • 00732094269246 ()
ELI230-ADC-ADXXX

  • Electrocardiograph, professional, multichannel

Welch Allyn, Inc. - 00732094269222

ELI230 12-Lead Multi-Channel Electrocardiograph -Color LCD display, AC or battery operation with WAM Wireless Acquisition Module (includes 1 starter roll paper - Thermal Roll appx 50 ft.); current software; International power cord; IEC 10 wire, 12-lead lead set with banana plugs; Adult and pediatric interpretation; No accessories; ; ;
WELCH ALLYN, INC.
901130
In Commercial Distribution

  • 00732094269222 ()
ELI230-ADD-ADXXX

  • Electrocardiograph, professional, multichannel

Welch Allyn, Inc. - 00732094269185

ELI230 12-Lead Multi-Channel Electrocardiograph -Color LCD display, AC or battery operation with WAM Wireless Acquisition Module (includes 1 starter roll paper - Thermal Roll appx 50 ft.); current software; International power cord; IEC 10 wire, 12-lead lead set with medi-clip ends; Adult and pediatric interpretation; No accessories; ; ;
WELCH ALLYN, INC.
901130
In Commercial Distribution

  • 00732094269185 ()
ELI230-ADF-ADXXX

  • Electrocardiograph, professional, multichannel

Welch Allyn, Inc. - 00732094029352

Welch Allyn SureTemp Plus 690 Handheld Electronic Thermometer with Interchangeable Oral Probe Well, Oral Probe with 4.0 ft/1.2 m Cord, Last Temperature Recall; 3 Alkaline AA Batteries, provides 4-6 Second Oral, 10-13 Second Pediatric Axillary, and 12-15 Second Adult Axillary Temperature Readings in Fahrenheit or Celsius
WELCH ALLYN, INC.
901053
In Commercial Distribution

  • 00732094029352 ()
01690-200

  • Ophthalmic/otologic diagnostic set

Welch Allyn, Inc. - 00732094029185

Welch Allyn SureTemp Plus 690 Wall-Mount Electronic Thermometer with Interchangeable Oral Probe Well, Oral Probe with 4.0 ft/1.2 m Cord, Last Temperature Recall; 3 Alkaline AA Batteries, provides 4-6 Second Oral, 10-13 Second Pediatric Axillary, and 12-15 Second Adult Axillary Temperature Readings in Fahrenheit or Celsius
WELCH ALLYN, INC.
901053
In Commercial Distribution

  • 00732094029185 ()
01690-400

  • Ophthalmic/otologic diagnostic set

Welch Allyn, Inc. - 00732094028966

Welch Allyn SureTemp Plus 692 Wall-Mount Electronic Thermometer (One per Room) with Interchangeable Oral Probe Well, Oral Probe with 9.0 ft/2.7 m Cord, Last Temperature Recall, 60-Second Pulse/Respiration Timer, Backlit Display with Electronic ID, Anti-Theft Security System; 3 Alkaline AA Batteries, provides 4-6 Second Oral
WELCH ALLYN, INC.
901053
In Commercial Distribution

  • 00732094028966 ()
01692-300

  • Ophthalmic/otologic diagnostic set

SINGLE CHAMBER BLANKET / FLUID WARMER - B286FHCSWC7218TL2201

Single chamber blanket/fluid warmer. 30"W X 20.5"D X 74.5"T 18" depth 21 Cubic ft. storage. Digital control. 2 Adjustable shelves. 2 Fixed Shelves. Foot levelers. Stainless steel door. Audible and visual over-temp alarm. Keyed temperature lock-out. Accuracy +/- 3 degrees F. Electrical: 220V
M.A.C. MEDICAL INC.
FHCSWC72-18-TL-220
In Commercial Distribution

  • B286FHCSWC7218TL2201 ()
FHCSWC72-18-TL-220

  • Blanket warming cabinet, dry-heat

SINGLE CHAMBER BLANKET / FLUID WARMER Overall Size Freestanding 24”W x 20.5”D x - B286FHCSWC2460TLG2201

Overall size 24”W x 20.5”D x 64.75”T. Chamber I.D. 20”W x 17”D x 49.5”T. 9.73 Cubic ft. storage. Digital control. 3 Adjustable shelves. Glass door. Audible and visual over-temp alarm. Foot levelers. Accuracy +/- 1 degrees F of set point. Electrical: 220V
M.A.C. MEDICAL INC.
FHCSWC2460-TL-G-220
In Commercial Distribution

  • B286FHCSWC2460TLG2201 ()
FHCSWC2460-TL-G-220

  • Blanket warming cabinet, dry-heat

COUNTER TOP BLANKET/FLUID WARMER Overall Size 24”W x 26.5”D x 24.5”T - B286FHCSWC2424TLG2201

Overall size 24”W x 26.5”D x 6 x 24.5”T. Chamber I.D. 20”W x 23”D x 15.25”T. 5.21 Cubic ft. storage. Digital control. Optional adjustable shelve. Glass door. Foot levelers. Audible and visual over-temp alarm. Accuracy +/- 1 degrees F. Electrical: 220V
M.A.C. MEDICAL INC.
FHCSWC2424-TL-G-220
In Commercial Distribution

  • B286FHCSWC2424TLG2201 ()
FHCSWC2424-TL-G-220

  • Blanket warming cabinet, dry-heat

COUNTER TOP BLANKET / FLUID WARMER Overall Size 30”W x 20.5”D x24.5”T - B286FHCSWC2418TLG2201

Overall size 30”W x 20.5”D x 6 x 24.5”T. Chamber I.D. 26”W x 17”D x 13.5”T. 3.45 Cubic ft. storage. Digital control. 1 Adjustable shelves. Glass door. Foot levelers. Audible and visual over-temp alarm. Accuracy +/- 1 degrees F. Electrical: 220V,
M.A.C. MEDICAL INC.
FHCSWC24-18-TL-G-220
In Commercial Distribution

  • B286FHCSWC2418TLG2201 ()
FHCSWC24-18-TL-G-220

  • Blanket warming cabinet, dry-heat

COUNTER TOP BLANKET / FLUID WARMER Overall Size 30”W x 20.5”D x24.5”T - B286FHCSWC2418TL2201

Overall size 30”W x 20.5”D x 6 x 24.5”T. Chamber I.D. 26”W x 17”D x 13.5”T. 3.45 Cubic ft. storage. Digital control. 1 Adjustable shelves. Stainless steel door. Foot levelers. Audible and visual over-temp alarm. Accuracy +/- 1 degrees F. Electrical: 220V
M.A.C. MEDICAL INC.
FHCSWC24-18-TL-220
In Commercial Distribution

  • B286FHCSWC2418TL2201 ()
FHCSWC24-18-TL-220

  • Blanket warming cabinet, dry-heat

SINGLE CHAMBER BLANKET / FLUID WARMER - B337FHCSWC7218TL2201

Single chamber blanket/fluid warmer. 30"W X 20.5"D X 74.5"T 18" depth 21 Cubic ft. storage. Digital control. 2 Adjustable shelves. 2 Fixed Shelves. Foot levelers. Stainless steel door. Audible and visual over-temp alarm. Keyed temperature lock-out. Accuracy +/- 3 degrees F. Electrical: 220V
FUTURE HEALTH CONCEPTS, INC.
FHCSWC72-18-TL-220
In Commercial Distribution

  • B337FHCSWC7218TL2201 ()
FHCSWC72-18-TL-220

  • Blanket warming cabinet, dry-heat

COUNTER TOP/WALL MOUNT BLANKET/FLUID WARMING CABINET - B337FHCSWC1518TLG2201

Overall size 18”W x 15.5”D x 22”T. Chamber I.D. 14”W x 13”D x 13”T. 1.4 Cubic ft. storage. Digital control. Full view glass door. Foot levelers. Audible and visual over-temp alarm. Accuracy +/- 1 degrees F. Electrical: 220V UL/CUL listed.
FUTURE HEALTH CONCEPTS, INC.
FHCSWC1518-TL-G-220
In Commercial Distribution

  • B337FHCSWC1518TLG2201 ()
FHCSWC1518-TL-G-220

  • Blanket warming cabinet, dry-heat

COUNTER TOP BLANKET/FLUID WARMER Overall Size 24”W x 26.5”D x 24.5”T - B337FHCSWC2424TLG2201

Overall size 24”W x 26.5”D x 6 x 24.5”T. Chamber I.D. 20”W x 23”D x 15.25”T. 5.21 Cubic ft. storage. Digital control. Optional adjustable shelve. Glass door. Foot levelers. Audible and visual over-temp alarm. Accuracy +/- 1 degrees F. Electrical: 220V
FUTURE HEALTH CONCEPTS, INC.
FHCSWC2424-TL-G-220
In Commercial Distribution

  • B337FHCSWC2424TLG2201 ()
FHCSWC2424-TL-G-220

  • Blanket warming cabinet, dry-heat

Vital Signs™ - 10889483602966

Vital Signs™ ABS Start Up Tubing Set, Adult, Disposable, 1.8 m/ 72 in 2 Gas Sampling Elbows, 2 Gas Sampling Line (3 m/10 ft.), 2 Vent Tubes, 0.9 m, 2 Bags, 2 L, 2 ABS Bag Arm Connector, Exhaust Lines, 0.18 m & 1 m
AirLife Finland Oy
M1093632
In Commercial Distribution

  • 10889483602966 ()
  • 10190752109131 ()
  • 20889483602963 ()
M1093632

  • Anaesthesia breathing circuit, single-use

Hoof VersaTek Wireless - B970HVW20

Includes 2 VersaTek Cuffs, 1 VersaTek Wireless Unit with Battery Pack Holder and Belt, Power Supply and AC Cord, Clinical Foot Software CD with Hoof-E Map, pre-configured wireless router, 4 Hoof 3200E Sensors, Li-Ion Battery Pack, Battery Pack Charger and Battery Pack Charger Power Supply, 6.5 ft. Mini A/B USB Cable, (2) 10 ft. Cuff Cables, Waist Belt, Elastic Take-Up Belt, Elastic Belt Extension, 2 Arm/Leg Straps, 2 Velcro Cable Ties, 2 Velcro Wrist/Ankle Bands, (4) 6188 Urethane Sensor Protective Sheets, Sensor Carrying Case, System Carrying Case, and 1 Training Session (USA Only)
Tekscan, Inc.
Hoof VersaTek Wireless System
In Commercial Distribution

  • B970HVW20 ()
HVW2

  • Body-surface pressure mapping system

CONFORMat VersaTek Wireless - B970CVW20

Includes 2 VersaTek Cuffs, 1 VersaTek Wireless Unit with Battery Pack Holder and Belt, Power Supply and AC Cord, Line Filter, CONFORMat Clinical Software CD with CONFORMat and CONFORMat Dual Maps, Help File, PDF of System Manual and Wireless software features, Pre-configured wireless router, (2) 5330E Sensors, Li-Ion Battery Pack, Battery Pack Charger and Battery Pack Charger Power Supply, 6.5 ft. Mini USB Cable, (2) 4 ft. Cuff Cables, Elastic Take-Up Belt, Elastic Belt Extension, 2 Arm/Leg Straps, 2 Velcro Cable Ties, 2 Velcro Wrist/Ankle Bands, Sensor Carrying Tube, System Carrying Case, Quick Start Guide, and 1 Training Session (USA Only)
Tekscan, Inc.
CONFORMat 2 VersaTek Wireless System
In Commercial Distribution

  • B970CVW20 ()
CVW2

  • Body-surface pressure mapping system

CONFORMat VersaTek Wireless - B970CVW10

Includes 1 VersaTek Cuff, 1 VersaTek Wireless Unit with Battery Pack Holder and Belt, Power Supply and AC Cord, Line Filter, CONFORMat Clinical Software CD with CONFORMat Map, Help File, PDF of System Manual, Pre-configured wireless router, (1) 5330E Sensor, Li-Ion Battery Pack, Battery Pack Charger and Battery Pack Charger Power Supply, 6.5 ft. Mini USB Cable, (1) 4 ft. Cuff Cables, Elastic Take-Up Belt, Elastic Belt Extension, 1 Arm/Leg Strap, 1 Velcro Cable Tie, 1 Velcro Wrist/Ankle Band, Sensor Carrying Tube, System Carrying Case, Quick Start Guide, and 1 Training Session (USA Only)
Tekscan, Inc.
CONFORMat 1 VersaTek Wireless System
In Commercial Distribution

  • B970CVW10 ()
CVW1

  • Body-surface pressure mapping system

DUAL CHAMBER BLANKET/FLUID WARMER - B286DWC243074EGMB1

Overall size 30”W x 26.5”D x 6 x 74.5”T. Upper Chamber I.D. 26”W x 23”D x 25”T 8.63 Cubic ft. storage. Lower chamber I.D. 26 “W x 23”D x 26”T 8.96 Cubic ft. storage. Digital control. 4 Adjustable shelves. Full view glass doors. Audible and visual over-temp alarm. Keyed temperature lock for each chamber, Door lock upper chamber. Accuracy +/- 2 degrees F (upper chamber). Accuracy +/- 2 degrees F (lower chamber). Electrical: 120V, 15 Amp, 50/60 Hz. .69kw/hr, 2356 btu/hr. UL/CUL listed. T0087 Mobile Base included PREVIOUS WARMER DWC36-TL-G-MB
M.A.C. MEDICAL INC.
DWC243074E-G-MB
In Commercial Distribution

  • B286DWC243074EGMB1 ()
DWC243074E-G-MB

  • Blanket warming cabinet, dry-heat

DUAL CHAMBER WARMING CABINET GLASS DOOR - B286DWC183074TGNBR21

Overall size 30”W x 26.5”D x 6 x 74.5”T. Upper Chamber I.D. 26”W x 23”D x 15.25”T 17.2 Cubic ft. storage. Lower chamber I.D. 26 “W x 23”D x 34.5”T 11.93 Cubic ft. storage. Digital control. 3 Adjustable shelves. Full view glass doors. Audible and visual over-temp alarm. Recessed with top, sides, and trim kit Upper chamber door lock Data logger No base Accuracy +/- 1 degrees F (upper chamber). Accuracy +/- 3 degrees F (lower chamber). Electrical: 120V, 15 Amp, 50/60 Hz. .75kw/hr, 2557 btu/hr. UL/CUL listed.
M.A.C. MEDICAL INC.
DWC183074T-G-NB-R2
In Commercial Distribution

  • B286DWC183074TGNBR21 ()
DWC183074T-G-NB-R2

  • Blanket warming cabinet, dry-heat

DUAL CHAMBER WARMING CABINET GLASS DOOR - B286DWC183074TGLH4B1

Overall size 30”W x 18”D x 6 x 74.5”T. Upper Chamber I.D. 26”W x 17”D x 15.25”T 17.2 Cubic ft. storage. Lower chamber I.D. 26 “W x 17”D x 34.5”T 11.93 Cubic ft. storage. Digital control. Foot levelers 3 Adjustable shelves. Glass doors. Audible and visual over-temp alarm. Data logger Keyed temperature lock Left hand hinge Upper chamber door lock 4" base Accuracy +/- 1 degrees F (upper chamber). Accuracy +/- 3 degrees F (lower chamber). Electrical: 120V, 15 Amp, 50/60 Hz. .75kw/hr, 2557 btu/hr. UL/CUL listed.
M.A.C. MEDICAL INC.
DWC183074T-G-LH-4B
In Commercial Distribution

  • B286DWC183074TGLH4B1 ()
DWC183074T-G-LH-4B

  • Blanket warming cabinet, dry-heat

DUAL CHAMBER WARMING CABINET GLASS DOOR - B286DWC183074TG4BR1

Overall size 30”W x 18”D x 6 x 74.5”T. Upper Chamber I.D. 26”W x 17”D x 15.25”T 17.2 Cubic ft. storage. Lower chamber I.D. 26 “W x 17”D x 34.5”T 11.93 Cubic ft. storage. Digital control. Foot levelers, Data logger, 4" base, recessed 3 Adjustable shelves. Stainless steel doors. Audible and visual over-temp alarm. Keyed temperature lock, Upper chamber door lock Accuracy +/- 1 degrees F (upper chamber). Accuracy +/- 3 degrees F (lower chamber). Electrical: 120V, 15 Amp, 50/60 Hz. .75kw/hr, 2557 btu/hr. UL/CUL listed.
M.A.C. MEDICAL INC.
DWC183074T-G-4B-R
In Commercial Distribution

  • B286DWC183074TG4BR1 ()
DWC183074T-G-4B-R

  • Blanket warming cabinet, dry-heat
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