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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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Nipro SafeTouch TULIP Safety Fistula Needle - 00383790000376

SafeTouch Tulip Safety AVF (15Gx1") 12" tube, rotating hub
NIPRO MEDICAL CORPORATION
FT+152530BCR
In Commercial Distribution

  • 10383790000373 ()
  • 00383790000376 ()
  • 40383790000374 ()


  • Haemodialysis needle

Nipro SafeTouch TULIP Safety Fistula Needle - 00383790000369

SafeTouch Tulip Safety AVF (15Gx1") 12" tube, fixed hub
NIPRO MEDICAL CORPORATION
FT+152530BC
In Commercial Distribution

  • 10383790000366 ()
  • 00383790000369 ()
  • 40383790000367 ()


  • Haemodialysis needle

Nipro SafeTouch TULIP Safety Fistula Needle - 00383790000345

SafeTouch Tulip Safety AVF (14Gx1") 12" tube, fixed hub (twin pack)
NIPRO MEDICAL CORPORATION
FT+142530TP
In Commercial Distribution

  • 00383790000345 ()


  • Haemodialysis needle

Nipro SafeTouch TULIP Safety Fistula Needle - 00383790000307

SafeTouch Tulip Safety AVF (14Gx1") 12" tube, fixed hub
NIPRO MEDICAL CORPORATION
FT+142530BC
In Commercial Distribution

  • 10383790000304 ()
  • 00383790000307 ()
  • 40383790000305 ()


  • Haemodialysis needle

Halyard - 10680651947281

HALYARD* Thermal Pad - Split Torso-5 ft. 3 in. - 5 ft. 8 in.-Medium
O&M HALYARD, INC.
94728
In Commercial Distribution

  • 30680651947285 ()
  • 10680651947281 ()
00315-05Z -No C

  • External circulating-fluid core temperature regulation system pad, reusable

Umbilical Cable - 08714729863175

Umbilical Cable
BOSTON SCIENTIFIC CORPORATION
M004RAUMBILICAL20
In Commercial Distribution

  • 08714729863175 ()

  • 2 m Length
  • 6.6 ft Length


  • Electrical-only medical device connection cable, single-use

EndoStat - 00878953000046

0.2mm 12ft
AMERICAN MEDICAL SYSTEMS
0010-0952
Not in Commercial Distribution

  • 00878953000046 ()

  • 0.2mm x 12 ft Fiber Core


  • General/multiple surgical laser system beam guide, reusable

HomeChoice PRO APD System - 00085412026350

The HomeChoice PRO Automated Personal Cycler is intended for automatic control of dialysate solution exchanges in the treatment of pediatric and adult renal failure patients undergoing peritoneal dialysis.
BAXTER INTERNATIONAL INC.
5C8310R
In Commercial Distribution

  • 00085412026350 ()
5C8310R

  • Peritoneal dialysis system

HomeChoice APD System - 00085412007021

The HomeChoice Automated Personal Cycler is intended for automatic control of dialysate solution exchanges in the treatment of pediatric and adult renal failure patients undergoing peritoneal dialysis.
BAXTER INTERNATIONAL INC.
5C4471
In Commercial Distribution

  • 00085412007021 ()
5C4471

  • Peritoneal dialysis system

QuickTalker FT 23 - 00186648000814

The QuickTalker FeatherTouch 23 speech device provides multi-message communication that is highly portable, durable, and easy to use. The FeatherTouch membrane responds to the lightest touches and smallest fingers, and makes it easy for almost anyone to communicate. QuickTalker FeatherTouch 23 includes 103 unique messages available across five recording levels and provides an individual with robust communication options throughout the day.
Ablenet, Inc.
10000038
In Commercial Distribution

  • 00186648000814 ()
10000038

  • Assistive speech generator
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