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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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DIASOL - B467100122575100

Diasol Liquid Acid Concentrate for Bicarbonate Dialysis
DIASOL, INC.
1001225-75100
In Commercial Distribution

  • B4671001225751004 ()
  • B467100122575100 ()
  • B46710012257510055 ()
ACD17

  • Haemodialysis concentrate

DIASOL - B46710012075200

Diasol Liquid Acid Concentrate for Bicarbonate Dialysis
DIASOL, INC.
100120-75200
In Commercial Distribution

  • B4671001207520055 ()
  • B46710012075200 ()
  • B467100120752004 ()
ACD1-ACG7

  • Haemodialysis concentrate

DIASOL - B46710012010100

Diasol Liquid Acid Concentrate for Bicarbonate Dialysis
DIASOL, INC.
100120-10100
In Commercial Distribution

  • B467100120101004 ()
  • B46710012010100 ()
  • B4671001201010055 ()
ACGG41

  • Haemodialysis concentrate

DIASOL - B46710010075200

Diasol Liquid Acid Concentrate for Bicarbonate Dialysis
DIASOL, INC.
100100-75200
In Commercial Distribution

  • B467100100752004 ()
  • B46710010075200 ()
  • B4671001007520055 ()
ACG6

  • Haemodialysis concentrate

DIASOL - B46710010010100

Diasol Liquid Acid Concentrate for Bicarbonate Dialysis
DIASOL, INC.
100100-10100
In Commercial Distribution

  • B4671001001010055 ()
  • B46710010010100 ()
  • B467100100101004 ()
ACG37

  • Haemodialysis concentrate

DIASOL - B46710002575200

Diasol Liquid Acid Concentrate for Bicarbonate Dialysis
DIASOL, INC.
100025-75200
In Commercial Distribution

  • B4671000257520055 ()
  • B46710002575200 ()
  • B467100025752004 ()
ACG5

  • Haemodialysis concentrate

DIASOL - B467100022510100

Diasol Liquid Acid Concentrate for Bicarbonate Dialysis
DIASOL, INC.
1000225-10100
In Commercial Distribution

  • B4671000225101004 ()
  • B467100022510100 ()
  • B46710002251010055 ()
ACG33

  • Haemodialysis concentrate

DIASOL - B46710001575100

Diasol Liquid Acid Concentrate for Bicarbonate Dialysis
DIASOL, INC.
100015-75100
In Commercial Distribution

  • B4671000157510055 ()
  • B46710001575100 ()
  • B467100015751004 ()
ACG31

  • Haemodialysis concentrate

DIASOL - B46710000075100

Diasol Liquid Acid Concentrate for Bicarbonate Dialysis
DIASOL, INC.
100000-75100
In Commercial Distribution

  • B467100000751004 ()
  • B46710000075100 ()
  • B4671000007510055 ()
ACD15-ACG30

  • Haemodialysis concentrate

ISEN-Goggles - B499V060

The !SEN-Goggles are used in the assessment of nystagmus by measuring, recording, displaying, and analyzing eye movements. This device consists of patient eye goggles ("ISEN-Goggles"). They have an adjustable, elastic headband, an LCD display, two green LED lights to provide optional focal points, eight infrared LED lights to provide illumination for the internal cameras, an internal SD-type memory, and buttons to operate the device's function. There is also a micro-USS port to facilitate transfer of data captured and stored in the device's SD-type memory. The patient eye goggles are an opaque, facially worn device fitted with two small video cameras, and two wavelengths of light emitting diodes (LEDs). One set of lights provides illumination for the cameras. The other allows the user to provide a focus point for the patient, if this is desired. These signals are processed by the image processor that allows for near-simultaneous viewing of the video images from both eyes on the attached LCD screen.
ISEN Tech. & Trading Co.,Ltd.
V06
In Commercial Distribution

  • B499V062 ()
  • B499V061 ()
  • B499V060 ()


  • Nystagmus inducing optokinetic drum
  • Nystagmus inducing tape

Vitale - B492245060

Vitale Cover Dressings, 6" x 6", 30/box, 10 boxes/case
CELLERA LLC
24506
In Commercial Distribution

  • B492245062 ()
  • B492245061 ()
  • B492245060 ()
24506

  • Exudate-absorbent dressing, non-gel, non-antimicrobial

Vitale - B492245040

Vitale Cover Dressings, 4" x 4", 30/box, 8 boxes/case
CELLERA LLC
24504
In Commercial Distribution

  • B492245042 ()
  • B492245041 ()
  • B492245040 ()
24504

  • Exudate-absorbent dressing, non-gel, non-antimicrobial

Vitale - B492212900

Vitale Sacral Hydrocolloid Dressing, 6x7, 1/pouch, 10/box, 10 boxes/case
CELLERA LLC
21290
In Commercial Distribution

  • B492212900 ()
  • B492212901 ()
  • B492212902 ()
21290

  • Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial

Vitale - B492212220

Vitale Hydrocolloid Dressings, 2" x 2", 1/pouch, 10/box, 10 boxes/case
CELLERA LLC
21222
In Commercial Distribution

  • B492212222 ()
  • B492212221 ()
  • B492212220 ()
21222

  • Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial

Vitale - B492208440

Vitale Hydroconductive Dressings, 4" x 4", 1/pouch, 10/box, 10 boxes/case
CELLERA LLC
20844
In Commercial Distribution

  • B492208442 ()
  • B492208441 ()
  • B492208440 ()
20844

  • Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial

Vitale - B492208000

Vitale Hydroconductive Ropes, 1/pouch, 5/box, 10 boxes/case
CELLERA LLC
20800
In Commercial Distribution

  • B492208002 ()
  • B492208001 ()
  • B492208000 ()
20800

  • Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial

Vitale - B492206220

Vitale Calcium Alginate Dressings, 2" x 2", 10/box, 10 boxes/case
CELLERA LLC
20622
In Commercial Distribution

  • B492206222 ()
  • B492206221 ()
  • B492206220 ()
20622

  • Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial

Vitale - B492205450

Vitale Calcium Alginate Dressings with Antibacterial Silver, 4"x 5", 10/box, 10 boxes/case
CELLERA LLC
20545
In Commercial Distribution

  • B492205452 ()
  • B492205451 ()
  • B492205450 ()
20545

  • Exudate-absorbent dressing, hydrophilic-gel, antimicrobial

Vitale - B492205440

Vitale Calcium Alginate Dressings with Antibacterial Silver, 4"x4", 10/box, 10 boxes/case
CELLERA LLC
20544
In Commercial Distribution

  • B492205442 ()
  • B492205441 ()
  • B492205440 ()
20544

  • Exudate-absorbent dressing, hydrophilic-gel, antimicrobial

Vitale - B492205000

Vitale Calcium Alginate Ropes with Antibacterial Silver, 5/box, 10 boxes/case
CELLERA LLC
20500
Not in Commercial Distribution

  • B492205002 ()
  • B492205001 ()
  • B492205000 ()
20500

  • Exudate-absorbent dressing, hydrophilic-gel, antimicrobial

Vitale - B492204440

Vitale Non-Adhesive Foam Dressings, 4" x 4", 10/box, 10 boxes/case
CELLERA LLC
20444
Not in Commercial Distribution

  • B492204442 ()
  • B492204441 ()
  • B492204440 ()
20444

  • Exudate-absorbent dressing, non-gel, non-antimicrobial

Vitale - B492203660

Vitale Adhesive Foam Dressing, 6"x6", 10/box, 10 boxes/case
CELLERA LLC
20366
In Commercial Distribution

  • B492203662 ()
  • B492203661 ()
  • B492203660 ()
20366

  • Exudate-absorbent dressing, non-gel, non-antimicrobial

Vitale - B492202800

Vitale Silicone Super-Absorbent Dressings, 8" x 10", 10/box, 10 boxes/case
CELLERA LLC
20280
Not in Commercial Distribution

  • B492202803 ()
  • B492202801 ()
  • B492202800 ()
20280

  • Exudate-absorbent dressing, non-gel, non-antimicrobial

Vitale - B492201900

Vitale Sacral Silicone Foam Dressing, 7" x 6 3/4", 5/box, 10 boxes/case
CELLERA LLC
20190
Not in Commercial Distribution

  • B492201901 ()
  • B492201900 ()
  • B492201903 ()
20190

  • Exudate-absorbent dressing, non-gel, non-antimicrobial

Checkpoint Head & Neck - B13093941

Surgical Nerve Stimulator/Locator
Checkpoint Surgical, Inc.
9394
In Commercial Distribution

  • B13093941 ()
  • B13093942 ()
  • B13093943 ()


  • Nerve-locating system

Checkpoint - B13090941

Surgical Nerve Stimulator/Locator
Checkpoint Surgical, Inc.
9094
In Commercial Distribution

  • B13090941 ()
  • B13090942 ()
  • B13090943 ()


  • Nerve-locating system

STINGRAY SURGICAL PRODUCTS - B112S048000

Disposable Bipolar Cord Straight 12 FT
STINGRAY SURGICAL PRODUCTS, LLC
S04-800
Not in Commercial Distribution

  • B112S048000 ()
  • B112S048001 ()
  • B112S048002 ()


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

Rescuer 7000-AD Replacement Suction Canister kit - B0027000AD0

Replacement canister kit and catheters for 7000-MVP
B.L.S. Systems Limited
7000-AD
In Commercial Distribution

  • B0027000AD9 ()
  • B0027000AD0 ()
  • B0027000AD2 ()
7000-AD

  • Emergency airway clearance suction pump, manual

Rescuer O-Mask Oxygen Mask with Universal Tubing - B0026210U0

Rescuer O-Mask Oxygen Mask with Universal Tubing (Child)
B.L.S. Systems Limited
6210-U
In Commercial Distribution

  • B0026210U7 ()
  • B0026210U0 ()
  • B0026210U9 ()

  • Child
6210-U

  • Non-rebreathing oxygen face mask

O-Mask Oxygen Mask, Child - B00262100

O-Mask Oxygen Mask, Child
B.L.S. Systems Limited
6210
In Commercial Distribution

  • B00262107 ()
  • B00262100 ()
  • B00262109 ()

  • Child
6210

  • Non-rebreathing oxygen face mask

Rescuer O-Mask with Universal Oxygen Tubing (Small Adult) - B0026205U0

Rescuer O-Mask with Universal Oxygen Tubing (Small Adult)
B.L.S. Systems Limited
6205-U
In Commercial Distribution

  • B0026205U7 ()
  • B0026205U0 ()
  • B0026205U9 ()

  • Small Adult
6205-U

  • Non-rebreathing oxygen face mask

O-Mask Oxygen Mask, Small Adult - B00262050

O-Mask Oxygen Mask, Small Adult
B.L.S. Systems Limited
6205
In Commercial Distribution

  • B00262057 ()
  • B00262050 ()
  • B00262059 ()

  • Small Adult
6205

  • Non-rebreathing oxygen face mask

Rescuer O-Mask - B0026200U0

Rescuer O-Mask with Universal Tubing (Large Adult)
B.L.S. Systems Limited
6200-U
In Commercial Distribution

  • B0026200U0 ()
  • B0026200U7 ()
  • B0026200U9 ()

  • Large Adult
6200-U

  • Non-rebreathing oxygen face mask

O-Mask Oxygen Mask, Large Adult - B00262000

O-Mask Oxygen Mask, Large Adult
B.L.S. Systems Limited
6200
In Commercial Distribution

  • B00262007 ()
  • B00262000 ()
  • B00262009 ()

  • Large Adult
6200

  • Non-rebreathing oxygen face mask

Rescuer Flo2Max Oxygen Mask, Child - B0026110U0

Rescuer Flo2Max Oxygen Mask with Universal Tubing, Child
B.L.S. Systems Limited
6110-U
In Commercial Distribution

  • B0026110U7 ()
  • B0026110U0 ()
  • B0026110U9 ()

  • Child
6110-U

  • Non-rebreathing oxygen face mask

Rescuer Flo2Max Oxygen Mask, Small Adult - B0026105U0

Rescuer Flo2Max Oxygen Mask with Universal tubing, Small Adult
B.L.S. Systems Limited
6105-U
In Commercial Distribution

  • B0026105U7 ()
  • B0026105U0 ()
  • B0026105U9 ()

  • Small Adult
6105-U

  • Non-rebreathing oxygen face mask

Flo2Max Adult Small Oxygen Mask - B00261050

Flo2Max 5-in-1 Oxygen Mask, Adult Small
B.L.S. Systems Limited
6105
In Commercial Distribution

  • B00261057 ()
  • B00261050 ()
  • B00261059 ()

  • Small Adult
6105

  • Non-rebreathing oxygen face mask

Rescuer Flo2Max Oxygen Mask, Large Adult - B0026100U0

Rescuer Flo2Max Oxygen Mask with Universal Tubing, Large Adult
B.L.S. Systems Limited
6100
In Commercial Distribution

  • B0026100U7 ()
  • B0026100U0 ()
  • B0026100U9 ()

  • Large Adult
6100-U

  • Non-rebreathing oxygen face mask

Rescuer Flo2Max Oxygen Mask - B00261000

Flo2Max 5-in-1 Oxygen Mask, Large Adult
B.L.S. Systems Limited
6100
In Commercial Distribution

  • B00261007 ()
  • B00261000 ()
  • B00261009 ()

  • Adult Large
6100

  • Non-rebreathing oxygen face mask

Rescuer BVM Manual Resuscitator - B00240500

Rescuer disposable adult manual resuscitator with pressure release valve, 2900 mL reservoir, #5 cushion mask and 2 m crush proof oxygen tubing
B.L.S. Systems Limited
4050
In Commercial Distribution

  • B00240506 ()
  • B00240500 ()
  • B00240501 ()

  • Adult
4050

  • Pulmonary resuscitator, manual, single-use
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