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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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Softener Tank - B297KAMT5F15408BT20

Softener Tank (8 cu ft), 24 x 72, Fleck SXT 2850, 15 DLFC, 1/2" BDT 240,000 Grain
SPECIALITY WATER TECHNOLOGY
K-A-MT-5F15-408-BT2
In Commercial Distribution

  • B297KAMT5F15408BT20 ()


  • Combination water purification system

Softener Tank - B297KAMT5F15407BT20

Softener Tank (7 cu ft), 24 x 72, Fleck SXT 2850, 15 DLFC, 1/2" BDT 240,000 Grain
SPECIALITY WATER TECHNOLOGY
K-A-MT-5F15-407-BT2
In Commercial Distribution

  • B297KAMT5F15407BT20 ()


  • Combination water purification system

Softener Tank - B297KAMT5E64307BT20

Softener Tank (7 cu ft), 21 x 62, Fleck SXT 2815, 12 DLFC, 1/2" BDT 210,000 Grain
SPECIALITY WATER TECHNOLOGY
K-A-MT-5E64-307-BT2
In Commercial Distribution

  • B297KAMT5E64307BT20 ()


  • Combination water purification system

Softener Tank - B297KAMT5E64306BT20

Softener Tank (6 cu ft), 21 x 62, Fleck SXT 2815, 12 DLFC, 1/2" BDT 180,000 Grain
SPECIALITY WATER TECHNOLOGY
K-A-MT-5E64-306-BT2
In Commercial Distribution

  • B297KAMT5E64306BT20 ()


  • Combination water purification system

Softener Tank - B297KAMT5E14306BT20

Softener Tank (6 cu ft), 21 x 62, Fleck SXT 2850, 12 DLFC, 1/2" BDT 180,000 Grain
SPECIALITY WATER TECHNOLOGY
K-A-MT-5E14-306-BT2
In Commercial Distribution

  • B297KAMT5E14306BT20 ()


  • Combination water purification system

Softener Tank - B297KAMT5C63205BT20

Softener Tank (5 cu ft), 18 x 65, Fleck SXT 2815, 9 DLFC 1/2" BDT 150,000 Grain
SPECIALITY WATER TECHNOLOGY
K-A-MT-5C63-205-BT2
In Commercial Distribution

  • B297KAMT5C63205BT20 ()


  • Combination water purification system

Softener Tank - B297KAMT5C13205BT20

Softener Tank (5 cu ft), 18 x 65, Fleck SXT 2850, 9 DLFC 1/2" BDT 150,000 Grain
SPECIALITY WATER TECHNOLOGY
K-A-MT-5C13-205-BT2
In Commercial Distribution

  • B297KAMT5C13205BT20 ()


  • Combination water purification system

Softener Tank - B297KAMT5B62104BT10

Softener Tank (4 cu ft), 16 x 65, Fleck SXT 2815, 7 DLFC, 1/2" BDT 120,000 Grain
SPECIALITY WATER TECHNOLOGY
K-A-MT-5B62-104-BT1
In Commercial Distribution

  • B297KAMT5B62104BT10 ()


  • Combination water purification system

Softener Tank - B297KAMT5B32104BT10

Softener Tank (4 cu ft), 16 x 65, Fleck SXT 2750, 7 DLF, 3/8" BDT 120,000 Grain
SPECIALITY WATER TECHNOLOGY
K-A-MT-5B32-104-BT1
In Commercial Distribution

  • B297KAMT5B32104BT10 ()


  • Combination water purification system

Multi-Media Filter - B297KAMT1K25PK0

Multimedia Filter Tank, 24" x 72", 2850-s Fleck w/SXT Digital Backwash (10 cu ft Filter Pack Kit)
SPECIALITY WATER TECHNOLOGY
K-A-MT-1K25-PK
In Commercial Distribution

  • B297KAMT1K25PK0 ()


  • Particulate water purification filter

PowerPICC SOLO2 FT Catheter with Sherlock Tip Location System (TLS) Stylet - 00801741035784

PowerPICC SOLO2 FT Catheter with Sherlock Tip Location System (TLS) Stylet 5F Maximal Barrier Tray with Microintroducer (Dual-Lumen)
Bard Access Systems, Inc.
9295108FD
In Commercial Distribution

  • 10801741035781 ()
  • 00801741035784 ()

  • Length: 55 Centimeter
  • Catheter Gauge: 5 French
9295108FD

  • Peripherally-inserted central venous catheter

UltraPoint™ - 10816843024373

TE: DISPOSABLE ULTRAPOINT MONOPOLAR NEEDLE ELECTRODES: 26 GA., 75 MM NEEDLE, 2.5 FT. (0.76 M) SINGLE GREEN LEADWIRE
ROCHESTER ELECTRO-MEDICAL, INC.
016397
Not in Commercial Distribution

  • 10816843024380 ()
  • 10816843024373 ()


  • Electromyographic needle electrode, single-use

UltraPoint™ - 10816843024335

TE: DISPOSABLE ULTRAPOINT MONOPOLAR NEEDLE ELECTRODES: 26 GA., 37 MM NEEDLE, 2.5 FT. (0.76 M) SINGLE GREEN LEADWIRE
ROCHESTER ELECTRO-MEDICAL, INC.
016393
Not in Commercial Distribution

  • 10816843024342 ()
  • 10816843024335 ()


  • Electromyographic needle electrode, single-use

UltraPoint™ - 10816843024311

TE: DISPOSABLE ULTRAPOINT MONOPOLAR NEEDLE ELECTRODES: 27 GA., 50 MM NEEDLE, 2.5 FT. (0.76 M) SINGLE BLUE LEADWIRE
ROCHESTER ELECTRO-MEDICAL, INC.
016391
Not in Commercial Distribution

  • 10816843024328 ()
  • 10816843024311 ()


  • Electromyographic needle electrode, single-use

UltraPoint™ - 10816843024298

TE: DISPOSABLE ULTRAPOINT MONOPOLAR NEEDLE ELECTRODES: 27 GA., 37 MM NEEDLE, 2.5 FT. (0.76 M) SINGLE BLUE LEADWIRE
ROCHESTER ELECTRO-MEDICAL, INC.
016388
Not in Commercial Distribution

  • 10816843024304 ()
  • 10816843024298 ()


  • Electromyographic needle electrode, single-use

UltraPoint™ - 10816843024250

TE: DISPOSABLE ULTRAPOINT MONOPOLAR NEEDLE ELECTRODES: 28 GA., 45 MM NEEDLE, 2.5 FT. (0.76 M) SINGLE ORANGE LEADWIRE
ROCHESTER ELECTRO-MEDICAL, INC.
016384
Not in Commercial Distribution

  • 10816843024267 ()
  • 10816843024250 ()


  • Electromyographic needle electrode, single-use

UltraPoint™ - 10816843024212

TE: DISPOSABLE ULTRAPOINT MONOPOLAR NEEDLE ELECTRODES: 29 GA., 37 MM NEEDLE, 2.5 FT. (0.76 M) SINGLE RED LEADWIRE
ROCHESTER ELECTRO-MEDICAL, INC.
016380
Not in Commercial Distribution

  • 10816843024229 ()
  • 10816843024212 ()


  • Electromyographic needle electrode, single-use

GoldSelect™ - 10816843020191

DISPOSABLE GOLDSELECT CUP ELECTRODES: 9 MM STAMPED GOLD DISC, 5 FT. (1.5 M), SINGLE, PVC WIRE (25/PACK)
ROCHESTER ELECTRO-MEDICAL, INC.
003760-25
Not in Commercial Distribution

  • 10816843020191 ()
  • 10816843020207 ()


  • Analytical scalp electrode, single-use

GoldSelect™ - 10816843020153

DISPOSABLE GOLDSELECT CUP ELECTRODES: 9 MM STAMPED GOLD DISC, 4 FT. (1.2 M), SINGLE, PVC WIRE (25/PACK)
ROCHESTER ELECTRO-MEDICAL, INC.
003748-25
Not in Commercial Distribution

  • 10816843020153 ()
  • 10816843020160 ()


  • Analytical scalp electrode, single-use

GoldSelect™ - 10816843024403

DISPOSABLE GOLDSELECT CUP ELECTRODES: 9 MM STAMPED GOLD DISC, 5 FT. (1.5 M), SINGLE, PVC WIRE, MVAP LABEL
ROCHESTER ELECTRO-MEDICAL, INC.
DGE-60
Not in Commercial Distribution

  • 10816843024403 ()
  • 10816843024397 ()


  • Analytical scalp electrode, single-use
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