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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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Cryostore - 10816203020427

Cryostore 50 EVA Freezing Bag, 10 - 30 ml, "N" tube set, case of 12, singly packed
ORIGEN BIOMEDICAL, INC.
CS50NS
In Commercial Distribution

  • 10816203020427 ()
  • 20816203020424 ()


  • Blood/tissue storage/culture container

Cryostore - 10816203020410

Cryostore 50 EVA Freezing Bag, 10 - 30 ml, "N" Tubing Set, case of 24
ORIGEN BIOMEDICAL, INC.
CS50N
In Commercial Distribution

  • 20816203020417 ()
  • 10816203020410 ()
  • 00816203020413 ()


  • Blood/tissue storage/culture container

Cryostore - 10816203020403

Cryostore 500 EVA 3-Bag set with spike, 55-100ml, 1 set per pouch, case of 8 sets
ORIGEN BIOMEDICAL, INC.
CS500V3S
Not in Commercial Distribution

  • 10816203020403 ()
  • 20816203020400 ()


  • Blood/tissue storage/culture container

Cryostore - 10816203020397

Cryostore 500 EVA Freezing Bag, 55 - 100 ml, "N" Tubing Set, case of 12, singly packed in triple OW
ORIGEN BIOMEDICAL, INC.
CS500NSWT
Not in Commercial Distribution

  • 10816203020397 ()
  • 20816203020394 ()


  • Blood/tissue storage/culture container

Cryostore - 10816203020380

Cryostore 500 EVA Freezing Bag, 55 - 100 ml, "N" tube set, case of 12, double aseptic packed in OW
ORIGEN BIOMEDICAL, INC.
CS500NSW
In Commercial Distribution

  • 10816203020380 ()
  • 20816203020387 ()


  • Blood/tissue storage/culture container

Cryostore - 10816203020373

CryoStore 500 EVA Freezing Bag, 55-100ml, "N" Tube Set, double aseptically packed
ORIGEN BIOMEDICAL, INC.
CS500NS
In Commercial Distribution

  • 10816203020373 ()
  • 20816203020370 ()
CS500NS

  • Blood/tissue storage/culture container

Cryostore - 10816203020366

CryoStore 500 EVA Freezing Bag, 55-100ml, "N" Tube Set
ORIGEN BIOMEDICAL, INC.
CS500N
In Commercial Distribution

  • 20816203020363 ()
  • 10816203020366 ()
  • 00816203020369 ()
CS500N

  • Blood/tissue storage/culture container

Cryostore - 10816203020359

CryoStore 25 EVA Freezing Bag, 10-25ml, "N" Tube Set
ORIGEN BIOMEDICAL, INC.
CS25N
In Commercial Distribution

  • 20816203020356 ()
  • 10816203020359 ()
  • 00816203020352 ()
CS25N

  • Blood/tissue storage/culture container

Cryostore - 10816203020342

Cryostore 250 EVA Freezing Bag, 30 - 70 ml, "Y12" Tubing Set, case of 12, double packed
ORIGEN BIOMEDICAL, INC.
CS250Y12S
Not in Commercial Distribution

  • 10816203020342 ()
  • 20816203020349 ()


  • Blood/tissue storage/culture container

Cryostore - 10816203020335

CryoStore 250 EVA Freezing Bag, 30-70ml, "N" Tube Set, double aseptically packed in OW
ORIGEN BIOMEDICAL, INC.
CS250NSW
In Commercial Distribution

  • 10816203020335 ()
  • 20816203020332 ()
CS250NSW

  • Blood/tissue storage/culture container

Cryostore - 10816203020328

CryoStore 250 EVA Freezing Bag, 30-70ml, "N" Tube Set, double aseptically packed
ORIGEN BIOMEDICAL, INC.
CS250NS
In Commercial Distribution

  • 10816203020328 ()
  • 20816203020325 ()
CS250NS

  • Blood/tissue storage/culture container

Cryostore - 10816203020304

Cryostore 2000 EVA Freezing Bag, 180-450ml, "Y8" Tubing Set, double aseptically pouched in OW, case of 12
ORIGEN BIOMEDICAL, INC.
CS2000aY8SW
Not in Commercial Distribution

  • 10816203020304 ()
  • 20816203020301 ()


  • Blood/tissue storage/culture container

Cryostore - 10816203020298

Cryostore 1950 EVA Freezing Bag, "Y8" Tubing Set, double aseptically pouched in OW, case of 12
ORIGEN BIOMEDICAL, INC.
CS1950aY8SW
Not in Commercial Distribution

  • 10816203020298 ()
  • 20816203020295 ()


  • Blood/tissue storage/culture container

CryoStore Freezing Bag - 10816203024319

CryoStore 50 EVA Freezing Bag, 10-30ml, "M3" Tube Set
ORIGEN BIOMEDICAL, INC.
CS50M3
In Commercial Distribution

  • 20816203024316 ()
  • 10816203024319 ()
  • 00816203024312 ()
CS50M3

  • Blood/tissue storage/culture container

CryoStore Freezing Bag - 10816203024289

CryoStore 500 EVA Freezing Bag, 55-100ml, "Standard" Tube Set
ORIGEN BIOMEDICAL, INC.
CS500
In Commercial Distribution

  • 20816203024286 ()
  • 10816203024289 ()
  • 00816203024282 ()
CS500

  • Blood/tissue storage/culture container

CryoStore Freezing Bag - 10816203024241

CryoStore 50 EVA Freezing Bag, 10-30ml, "N" Tube Set
ORIGEN BIOMEDICAL, INC.
CS50N
In Commercial Distribution

  • 20816203024248 ()
  • 10816203024241 ()
  • 00816203024244 ()
CS50N

  • Blood/tissue storage/culture container

CryoStore Freezing Bag - 10816203024234

CryoStore 50 EVA Freezing Bag, 10-30ml, "Standard" Tube Set
ORIGEN BIOMEDICAL, INC.
CS50
In Commercial Distribution

  • 20816203024231 ()
  • 10816203024234 ()
  • 00816203024237 ()
CS50

  • Blood/tissue storage/culture container

CryoStore - 10816203023749

CryoStore 750 EVA Freezing Bag, 80-190ml, "K" Tube Set, double aseptically packed
ORIGEN BIOMEDICAL, INC.
CS750KS
In Commercial Distribution

  • 20816203023746 ()
  • 10816203023749 ()
CS750KS

  • Blood/tissue storage/culture container

CryoStore - 10816203023725

CryoStore 50 EVA Freezing Bag,10-30ml, "K" Tube Set, double aseptically packed
ORIGEN BIOMEDICAL, INC.
CS50KS
In Commercial Distribution

  • 20816203023722 ()
  • 10816203023725 ()
CS50KS

  • Blood/tissue storage/culture container

CryoStore - 10816203023640

CryoStore 250 EVA Freezing Bag, 30-70ml, "K" Tube Set, double aseptically packed
ORIGEN BIOMEDICAL, INC.
CS250S
In Commercial Distribution

  • 20816203023647 ()
  • 10816203023640 ()
CS250S

  • Blood/tissue storage/culture container

CryoStore - 10816203023589

CryoStore 20 FLEX EVA Freezing Bag, 20-30ml, “V” Tube Set
ORIGEN BIOMEDICAL, INC.
CS20V6
In Commercial Distribution

  • 20816203023586 ()
  • 10816203023589 ()
CS20V6

  • Blood/tissue storage/culture container

CryoStore - 10816203023572

CryoStore 20 FLEX EVA Freezing Bag, 20-30ml, “N” Tube Set, double aseptically packed
ORIGEN BIOMEDICAL, INC.
CS20NS
In Commercial Distribution

  • 20816203023579 ()
  • 10816203023572 ()
CS20NS

  • Blood/tissue storage/culture container

CryoStore - 10816203023565

CryoStore 20 FLEX EVA Freezing Bag, 20-30ml, “F” Tube Set
ORIGEN BIOMEDICAL, INC.
CS20F
In Commercial Distribution

  • 20816203023562 ()
  • 10816203023565 ()
  • 00816203023568 ()
CS20F

  • Blood/tissue storage/culture container

CryoStore - 10816203023558

CryoStore 20 EVA 5-Chamber Freezing Bag, 20-30ml, "N" Tube Set
ORIGEN BIOMEDICAL, INC.
CS20N
In Commercial Distribution

  • 20816203023555 ()
  • 10816203023558 ()
  • 00816203023551 ()
CS20N

  • Blood/tissue storage/culture container

Cryostore - 10816203023428

Cryostore 500 EVA Freezing Bag, 55-100ml, "N" Tube Set, singly packed
ORIGEN BIOMEDICAL, INC.
CS500NP
Not in Commercial Distribution

  • 20816203023425 ()
  • 10816203023428 ()
CS500NP

  • Blood/tissue storage/culture container

Cryostore - 10816203023305

CryoStore 50 EVA Freezing Bag, 7-Bag Set, 10-30ml, "V9" Tube Set
ORIGEN BIOMEDICAL, INC.
CS50V9
Not in Commercial Distribution

  • 20816203023302 ()
  • 10816203023305 ()


  • Blood/tissue storage/culture container

CryoStore - 10816203023152

CryoStore 500 EVA Freezing Bag, 8-bag set, 55-100ml, "V8" Tube Set
ORIGEN BIOMEDICAL, INC.
CS500V8
Not in Commercial Distribution

  • 20816203023159 ()
  • 10816203023152 ()


  • Blood/tissue storage/culture container

Crystore - 10816203022889

CryoStore 250 EVA Freezing Bag, 30-70ml, "N" Tube Set
ORIGEN BIOMEDICAL, INC.
CS250N
In Commercial Distribution

  • 10816203022889 ()
  • 00816203022882 ()
  • 20816203022886 ()
CS250N

  • Blood/tissue storage/culture container

Cryostore - 10816203022865

Cryostore 750 EVA Freezing Bag, 80 - 190 ml, "N" Tubing Set, case of 24
ORIGEN BIOMEDICAL, INC.
CS750N
In Commercial Distribution

  • 10816203022865 ()
  • 00816203022868 ()
  • 20816203022862 ()


  • Blood/tissue storage/culture container

Cryostore - 10816203022841

Cryostore 28 EVA Freezing Bag, 5-20 ml, F tube set, case of 24
ORIGEN BIOMEDICAL, INC.
CS28F
Not in Commercial Distribution

  • 10816203022841 ()
  • 20816203022848 ()
  • 00816203022844 ()


  • Blood/tissue storage/culture container

CryoStore - 10816203022292

Cryostore 2000 EVA Freezing Bag, 4-bag Set, 180-450ml, "V8" Tubing Set, double aseptically pouched.
ORIGEN BIOMEDICAL, INC.
CS2000V8S
Not in Commercial Distribution

  • 20816203022299 ()
  • 10816203022292 ()


  • Blood/tissue storage/culture container

Cryostore - 10816203022247

Cryostore 250 EVA Freezing Bag, 30 - 70 ml, "F1" Tubing Set, case of 24
ORIGEN BIOMEDICAL, INC.
CS250F1A
Not in Commercial Distribution

  • 20816203022244 ()
  • 10816203022247 ()
  • 00816203022240 ()


  • Blood/tissue storage/culture container

Cryostore - 10816203022230

Cryostore 2000 EVA Freezing Bag, 180-450ml, "Standard" Tube Set, case of 24
ORIGEN BIOMEDICAL, INC.
CS2000
Not in Commercial Distribution

  • 10816203022230 ()
  • 20816203022237 ()
  • 00816203022233 ()


  • Blood/tissue storage/culture container

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 - 10816203021424

Cryostore 750 EVA Freezing Bag, 80 - 190 ml, "F5" tube set, case of 24
ORIGEN BIOMEDICAL, INC.
CS750F5
Not in Commercial Distribution

  • 20816203021421 ()
  • 10816203021424 ()
  • 00816203021427 ()


  • 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 - 10816203021387

Cryostore 50 EVA 4- Bag Set, 10-30ml, "Standard" Tubing Set, 1 set per pouch, case of 6
ORIGEN BIOMEDICAL, INC.
CS50V4
Not in Commercial Distribution

  • 10816203021387 ()
  • 20816203021384 ()


  • 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 - 10816203021356

Cryostore 50 EVA Freezing Bag, 10 - 30 ml, standard tube set, case of 12, triply packed
ORIGEN BIOMEDICAL, INC.
CS50S-3
Not in Commercial Distribution

  • 10816203021356 ()
  • 20816203021353 ()


  • Blood/tissue storage/culture container

Cryostore - 10816203021332

Cryostore 50 EVA Freezing Bag, 10 - 30 ml, M3 tube set, case of 24
ORIGEN BIOMEDICAL, INC.
CS50M3
In Commercial Distribution

  • 20816203021339 ()
  • 10816203021332 ()
  • 00816203021335 ()


  • Blood/tissue storage/culture container

Cryostore - 10816203021318

Cryostore 50 EVA Freezing Bag, 10-30ml, "F4" Tubing Set, double aseptically pouched, case of 12
ORIGEN BIOMEDICAL, INC.
CS50F4S
Not in Commercial Distribution

  • 10816203021318 ()
  • 20816203021315 ()


  • Blood/tissue storage/culture container

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
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