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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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Typesafe 2.0 - 10812269031254

Typesafe 2.0 - Quantity 1000
TYPENEX MEDICAL LLC
SP0201QM
In Commercial Distribution

  • 00812269031264 ()
  • 10812269031254 ()
  • 00812269031257 ()


  • Blood donor bag segment sampling IVD

Haemonetics® NexSys PCS® System - 10812747019736

0625Q-00 Plasma Bowl
HAEMONETICS CORPORATION
0625Q-00
In Commercial Distribution

  • 30812747019730 ()
  • 10812747019736 ()


  • Apheresis system tubing set

Haemonetics® PCS®2 & NexSys PCS® Systems - 10812747019347

PLS HARNESS SET
HAEMONETICS CORPORATION
00620-CC
In Commercial Distribution

  • 30812747019341 ()
  • 10812747019347 ()


  • Apheresis system tubing set

Haemonetics® NexSys PCS® System - 10812747019330

0625Q-00 Plasma Bowl
HAEMONETICS CORPORATION
0625Q-00
In Commercial Distribution

  • 30812747019334 ()
  • 10812747019330 ()


  • Apheresis system tubing set

HAEMONETICS MCS+ (LN8150) AND RBC APHERISIS - 10812747013505

RBCF-2P SET
HAEMONETICS CORPORATION
0822F-2P
In Commercial Distribution

  • 30812747013509 ()
  • 10812747013505 ()


  • Apheresis system tubing set

HAEMONETICS MCS+ (LN8150) for RBC APHERESIS - 10812747013482

TWO UNIT RED CELLS DISPOSABLE SETS
HAEMONETICS CORPORATION
00832-00
In Commercial Distribution

  • 30812747013486 ()
  • 10812747013482 ()

  • Total Volume: 600 Milliliter
  • Total Volume: 1000 Milliliter
  • Total Volume: 275 Milliliter


  • Apheresis system tubing set

HAEMONETICS MCS+ (LN9000) SYSTEM - 10812747012270

MCS+ SDP/PLP CON FIL,994CF-CPP
HAEMONETICS CORPORATION
994CF-CPP
In Commercial Distribution

  • 10812747012270 ()
  • 30812747012274 ()

  • Total Volume: 1000 Milliliter
  • Total Volume: 225 Milliliter


  • Apheresis system tubing set

HAEMONETICS MCS+ APHERESIS SYSTEM - 10812747012096

MCS+ SDP/PLP W/SALINE,LN 994
HAEMONETICS CORPORATION
00994-00
In Commercial Distribution

  • 30812747012090 ()
  • 10812747012096 ()

  • Total Volume: 1000 Milliliter
  • Total Volume: 600 Milliliter
  • Total Volume: 50 Milliliter


  • Apheresis system tubing set

Haemonetics® PCS®2 & NexSys PCS™ Systems - 10812747011761

PLS Harness Set
HAEMONETICS CORPORATION
00620-CP
In Commercial Distribution

  • 30812747011765 ()
  • 10812747011761 ()


  • Apheresis system tubing set

Haemonetics® PCS®2 & NexSys PCS™ Systems - 10812747011754

PLS Harness Set
HAEMONETICS CORPORATION
00620-00
Not in Commercial Distribution

  • 30812747011758 ()
  • 10812747011754 ()


  • Apheresis system tubing set

Haemonetics® PCS®2, NexSys PCS® & MCS®+ Systems - 10812747011716

PLS Bag w/Vac Sampling
HAEMONETICS CORPORATION
SC690-00
In Commercial Distribution

  • 30812747011710 ()
  • 10812747011716 ()


  • Apheresis system tubing set

Haemonetics® PCS®2, NexSys PCS™ & MCS®+ Systems - 10812747011693

PLS Bag
HAEMONETICS CORPORATION
00690-00
In Commercial Distribution

  • 30812747011697 ()
  • 10812747011693 ()

  • Total Volume: 1000 Milliliter


  • Apheresis system tubing set

Typesafe - 10812269031278

Typesafe Segment Piercing Device
TYPENEX MEDICAL LLC
TS500
In Commercial Distribution

  • 20812269031275 ()
  • 10812269031278 ()
  • 00812269031271 ()


  • Blood donor bag segment sampling IVD

Typesafe 2.0 - 10812269031230

Typesafe 2.0 - Quantity 500
TYPENEX MEDICAL LLC
SP0201QD
In Commercial Distribution

  • 00812269031240 ()
  • 10812269031230 ()
  • 00812269031233 ()


  • Blood donor bag segment sampling IVD

Elecsys HIV combi PT - 04015630942497

HIV combi PT Elecsys cobas e 100
Roche Diagnostics GmbH
05390095160
In Commercial Distribution

  • 04015630942497 ()
05390095160

  • HIV1/HIV2 antigen/antibody IVD, kit, chemiluminescent immunoassay

Alere Determine™ HIV–1/2 Ag/Ab Combo Controls - 10811877010347

The Alere Determine™ HIV-1/2 Ag/Ab Combo Controls are quality control reagents for use with the Alere Determine™ HIV-1/2 Ag/Ab Combo Assay only.
Alere Scarborough, Inc.
7D2628
Not in Commercial Distribution

  • 10811877010347 ()


  • HIV1/HIV2 antigen/antibody IVD, control

Alere Determine™ HIV–1/2 Ag/Ab Combo - 10811877010323

Alere Determine™ HIV–1/2 Ag/Ab Combo is an in vitro, visually read, qualitative immunoassay for the simultaneous detection of HIV-1 p24 antigen (Ag) and antibodies (Ab) to HIV-1 and HIV-2 in human serum, plasma, capillary (fingerstick) whole blood or venipuncture (venous) whole blood.
Alere Scarborough, Inc.
7D2649
Not in Commercial Distribution

  • 10811877010323 ()


  • HIV1/HIV2 antigen/antibody IVD, kit, rapid ICT, clinical

Alere Determine™ HIV–1/2 Ag/Ab Combo - 10811877010293

Alere Determine™ HIV–1/2 Ag/Ab Combo is an in vitro, visually read, qualitative immunoassay for the simultaneous detection of HIV-1 p24 antigen (Ag) and antibodies (Ab) to HIV-1 and HIV-2 in human serum, plasma, capillary (fingerstick) whole blood or venipuncture (venous) whole blood.
Alere Scarborough, Inc.
7D2648
Not in Commercial Distribution

  • 10811877010293 ()


  • HIV1/HIV2 antigen/antibody IVD, kit, rapid ICT, clinical

Cryostore - 10816203021547

Cryostore 2500 Conical EVA Freezing Bag, 730-810ml, " Y14" Tubing Set, case of 12
ORIGEN BIOMEDICAL, INC.
CSD2500Y14
In Commercial Distribution

  • 10816203021547 ()
  • 20816203021544 ()


  • Blood/tissue storage/culture container

Cryostore - 10816203021530

Cryostore 750 EVA Freezing Bag, 80 - 190 ml, Standard Tubing Set, case of 24
ORIGEN BIOMEDICAL, INC.
CS750
In Commercial Distribution

  • 20816203021537 ()
  • 10816203021530 ()
  • 00816203021533 ()


  • Blood/tissue storage/culture container

Cryostore - 10816203021523

Cryostore 750 EVA Freezing Bag, 80 - 190 ml, "Y11" Tubing Set, case of 50
ORIGEN BIOMEDICAL, INC.
CS750Y11
Not in Commercial Distribution

  • 20816203021520 ()
  • 10816203021523 ()
  • 00816203021526 ()


  • Blood/tissue storage/culture container

Cryostore - 10816203021516

Cryostore 750 EVA Freezing Bag, 80 - 190 ml, "Y10" Tubing Set, case of 24
ORIGEN BIOMEDICAL, INC.
CS750Y10
Not in Commercial Distribution

  • 20816203021513 ()
  • 10816203021516 ()
  • 00816203021519 ()


  • Blood/tissue storage/culture container

Cryostore - 10816203021509

Cryostore 750 EVA 3-Bag set with drip spikes, 80-190ml, case of 6 sets
ORIGEN BIOMEDICAL, INC.
CS750V4
Not in Commercial Distribution

  • 10816203021509 ()
  • 20816203021506 ()


  • Blood/tissue storage/culture container

Cryostore - 10816203021493

Cryostore 750 EVA Freezing Bag, 80-190ml, 3- Bag set with "V3" Tube Set, 1 set per pouch, case of 8 sets
ORIGEN BIOMEDICAL, INC.
CS750V3
Not in Commercial Distribution

  • 10816203021493 ()
  • 20816203021490 ()


  • Blood/tissue storage/culture container

Cryostore - 10816203021455

Cryostore 750 EVA Freezing Bag, 80 - 190 ml, "M2" tube set, case of 12, double pouched
ORIGEN BIOMEDICAL, INC.
CS750M2S
Not in Commercial Distribution

  • 10816203021455 ()
  • 20816203021452 ()


  • Blood/tissue storage/culture container

Cryostore - 10816203021448

Cryostore 750 EVA Freezing Bag, 80 - 190 ml, "F8" tube set, case of 24
ORIGEN BIOMEDICAL, INC.
CS750F8
Not in Commercial Distribution

  • 20816203021445 ()
  • 10816203021448 ()
  • 00816203021441 ()


  • Blood/tissue storage/culture container

Cryostore - 10816203021431

Cryostore 750 EVA Freezing Bag, 80 - 190 ml, "F5" tube set, case of 20
ORIGEN BIOMEDICAL, INC.
CS750F5-2
Not in Commercial Distribution

  • 20816203021438 ()
  • 10816203021431 ()
  • 00816203021434 ()


  • Blood/tissue storage/culture container

Cryostore - 10816203021417

Cryostore 750 EVA Freezing Bag, 80 - 190 ml, F1 tube set, double aseptic packed, case of 12
ORIGEN BIOMEDICAL, INC.
CS750F1S
Not in Commercial Distribution

  • 10816203021417 ()
  • 20816203021414 ()


  • Blood/tissue storage/culture container

Cryostore - 10816203021363

Cryostore 50 EVA Freezing Bag, 10 - 30 ml, standard tube set, case of 12, singly packed in OW
ORIGEN BIOMEDICAL, INC.
CS50SW
Not in Commercial Distribution

  • 10816203021363 ()
  • 20816203021360 ()


  • Blood/tissue storage/culture container

Cryostore - 10816203021349

Cryostore 50 EVA Freezing Bag, 10 - 30 ml, standard tube set, case of 12, singly packed
ORIGEN BIOMEDICAL, INC.
CS50S
In Commercial Distribution

  • 10816203021349 ()
  • 20816203021346 ()


  • Blood/tissue storage/culture container

Cryostore - 10816203021325

Cryostore 50 EVA Freezing Bag, 10 - 30 ml, standard tube set, case of 24, heat sealed
ORIGEN BIOMEDICAL, INC.
CS50H
Not in Commercial Distribution

  • 20816203021322 ()
  • 10816203021325 ()
  • 00816203021328 ()


  • Blood/tissue storage/culture container

Cryostore - 10816203021264

Cryostore 500 EVA 3-Bag set with spikes, 55-100ml, 1 set per pouch, case of 8 sets
ORIGEN BIOMEDICAL, INC.
CS500V3
Not in Commercial Distribution

  • 10816203021264 ()
  • 20816203021261 ()


  • Blood/tissue storage/culture container

Cryostore - 10816203021233

Cryostore 500 EVA Freezing Bag, 55 - 100 ml Std.Tubing Set, case of 12, singly packed in OW
ORIGEN BIOMEDICAL, INC.
CS500SW
Not in Commercial Distribution

  • 10816203021233 ()
  • 20816203021230 ()


  • Blood/tissue storage/culture container

Cryostore - 10816203021226

Cryostore 500 EVA Freezing Bag, 55 - 100 ml Std.Tubing Set, case of 12, singly packed
ORIGEN BIOMEDICAL, INC.
CS500S
Not in Commercial Distribution

  • 10816203021226 ()
  • 20816203021223 ()


  • Blood/tissue storage/culture container

Cryostore - 10816203021219

Cryostore 500 EVA Freezing Bag, 55 - 100 ml "M4" Tubing Set, case of 24
ORIGEN BIOMEDICAL, INC.
CS500M4
Not in Commercial Distribution

  • 20816203021216 ()
  • 10816203021219 ()
  • 00816203021212 ()


  • Blood/tissue storage/culture container

Cryostore - 10816203021202

Cryostore 500 EVA Freezing Bag, custom length, Standard Tubing Set, case of 24
ORIGEN BIOMEDICAL, INC.
CS500i3
In Commercial Distribution

  • 20816203021209 ()
  • 10816203021202 ()
  • 00816203021205 ()


  • Blood/tissue storage/culture container

Cryostore - 10816203021196

Cryostore 500 EVA Bag, custom-width, N-tube set, in custom-width O-Wrap, case of 12
ORIGEN BIOMEDICAL, INC.
CS500i2PW
Not in Commercial Distribution

  • 10816203021196 ()
  • 20816203021193 ()


  • Blood/tissue storage/culture container

Cryostore - 10816203021189

Cryostore 500 EVA Freezing Bag, custom width, "N" Tubing Set, case of 12
ORIGEN BIOMEDICAL, INC.
CS500i2
Not in Commercial Distribution

  • 10816203021189 ()
  • 20816203021186 ()


  • Blood/tissue storage/culture container

Cryostore - 10816203021172

Cryostore 500 EVA Freezing Bag, custom width, "N" Tubing Set, case of 24
ORIGEN BIOMEDICAL, INC.
CS500i
Not in Commercial Distribution

  • 20816203021179 ()
  • 10816203021172 ()
  • 00816203021175 ()


  • Blood/tissue storage/culture container

Cryostore - 10816203021165

Cryostore 500 EVA Freezing Bag, 55 - 100 ml, "F1" Tubing Set, double aseptic packed, case of 12
ORIGEN BIOMEDICAL, INC.
CS500F1S
Not in Commercial Distribution

  • 10816203021165 ()
  • 20816203021162 ()


  • Blood/tissue storage/culture container
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