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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 - 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

Cryostore - 10816203021158

Cryostore 500 EVA Freezing Bag, 55 - 100 ml, "F16" Tubing Set, case of 24
ORIGEN BIOMEDICAL, INC.
CS500F16
Not in Commercial Distribution

  • 20816203021155 ()
  • 10816203021158 ()
  • 00816203021151 ()


  • Blood/tissue storage/culture container

Cryostore - 10816203021141

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

  • 20816203021148 ()
  • 10816203021141 ()
  • 00816203021144 ()
CS500

  • Blood/tissue storage/culture container

Cryostore - 10816203021134

Cryostore 50 EVA Freezing Bag, 10 - 30 ml, standard tube set, case of 12, 4 per triply pouched, 3 pouches per case
ORIGEN BIOMEDICAL, INC.
CS50-3
Not in Commercial Distribution

  • 20816203021131 ()
  • 10816203021134 ()
  • 00816203021137 ()


  • Blood/tissue storage/culture container

Cryostore - 10816203021127

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

  • 20816203021124 ()
  • 10816203021127 ()
  • 00816203021120 ()
CS50

  • Blood/tissue storage/culture container

Cryostore - 10816203021110

Cryostore 400ml EVA Freezing Bag with standard tube set, 24 per case
ORIGEN BIOMEDICAL, INC.
CS400
Not in Commercial Distribution

  • 20816203021117 ()
  • 10816203021110 ()
  • 00816203021113 ()


  • Blood/tissue storage/culture container

CryoStore Freezing Bag - 10816203021103

CryoStore 30 EVA Multi-Chamber Freezing Bag, 30ml, "M9" Tube Set
ORIGEN BIOMEDICAL, INC.
CS30M9
In Commercial Distribution

  • 20816203021100 ()
  • 10816203021103 ()
CS30M9

  • Blood/tissue storage/culture container

Cryostore - 10816203021097

CryoStore 28 EVA Freezing Bag, 10-25ml, "V" Tube Set
ORIGEN BIOMEDICAL, INC.
CS28V
In Commercial Distribution

  • 20816203021094 ()
  • 10816203021097 ()
  • 00816203021090 ()
CS28V

  • Blood/tissue storage/culture container

Cryostore - 10816203021080

CryoStore 25 EVA Freezing Bag, 10-25ml, "Y4" Tube Set
ORIGEN BIOMEDICAL, INC.
CS25Y4
In Commercial Distribution

  • 20816203021087 ()
  • 10816203021080 ()
  • 00816203021083 ()
CS25Y4

  • Blood/tissue storage/culture container

Cryostore - 10816203021073

Cryostore 25 EVA Freezing Bag, 10 - 25 ml, "Y2" tube set, case of 24
ORIGEN BIOMEDICAL, INC.
CS25Y2
Not in Commercial Distribution

  • 20816203021070 ()
  • 10816203021073 ()
  • 00816203021076 ()


  • Blood/tissue storage/culture container

Cryostore - 10816203021059

Dual Cryostore 25 EVA Freezing Bag, 10 - 25 ml, with two female luers, case of 12
ORIGEN BIOMEDICAL, INC.
CS25V2
Not in Commercial Distribution

  • 10816203021059 ()
  • 20816203021056 ()


  • Blood/tissue storage/culture container

Cryostore - 10816203021035

CryoStore 25 EVA Freezing Bag, 10-25ml, "N" Tube Set, double aseptically packed
ORIGEN BIOMEDICAL, INC.
CS25NS
In Commercial Distribution

  • 10816203021035 ()
  • 20816203021032 ()
CS25NS

  • Blood/tissue storage/culture container

Cryostore - 10816203020991

CryoStore 25 EVA Freezing Bag, 10-25ml, "F" Tube Set
ORIGEN BIOMEDICAL, INC.
CS25F
In Commercial Distribution

  • 20816203020998 ()
  • 10816203020991 ()
  • 00816203020994 ()
CS25F

  • Blood/tissue storage/culture container

Cryostore - 10816203020984

Cryostore 250 EVA Freezing Bag, 30 - 70 ml, Y12 Tubing Set, case of 12, singly packed
ORIGEN BIOMEDICAL, INC.
CS250Y12P
Not in Commercial Distribution

  • 10816203020984 ()
  • 20816203020981 ()


  • Blood/tissue storage/culture container

Cryostore - 10816203020977

Cryostore 250 EVA Freezing Bag, 30 - 70 ml, Std.Tubing Set, case of 12, singly packed in OW
ORIGEN BIOMEDICAL, INC.
CS250SW
Not in Commercial Distribution

  • 10816203020977 ()
  • 20816203020974 ()


  • Blood/tissue storage/culture container

Cryostore - 10816203020953

Cryostore 250 EVA Freezing Bag, 30 - 70 ml, "N" Tubing Set, case of 12, singly packed in triple OW
ORIGEN BIOMEDICAL, INC.
CS250NSWT
Not in Commercial Distribution

  • 10816203020953 ()
  • 20816203020950 ()


  • Blood/tissue storage/culture container

Cryostore - 10816203020922

Cryostore 250 EVA Freezing Bag, 30 - 70 ml, "F" Tubing Set, case of 12, singly packed
ORIGEN BIOMEDICAL, INC.
CS250FS
Not in Commercial Distribution

  • 10816203020922 ()
  • 20816203020929 ()


  • Blood/tissue storage/culture container

Cryostore - 10816203020915

Cryostore 250 EVA Freezing bag, 30-70ml with F7 Tube Set
ORIGEN BIOMEDICAL, INC.
CS250F7P
Not in Commercial Distribution

  • 10816203020915 ()
  • 20816203020912 ()


  • Blood/tissue storage/culture container

Cryostore - 10816203020892

Cryostore 250 EVA Freezing Bag, 30 - 70 ml, "F5" Tubing Set, case of 24
ORIGEN BIOMEDICAL, INC.
CS250F5
Not in Commercial Distribution

  • 20816203020899 ()
  • 10816203020892 ()
  • 00816203020895 ()


  • Blood/tissue storage/culture container

Cryostore - 10816203020885

Cryostore 250 EVA Freezing Bag, 30 - 70 ml, "F4" Tubing Set, double aseptic pouched, case of 12
ORIGEN BIOMEDICAL, INC.
CS250F4S
Not in Commercial Distribution

  • 10816203020885 ()
  • 20816203020882 ()


  • Blood/tissue storage/culture container

Cryostore - 10816203020878

Cryostore 250 EVA Freezing Bag, 30 - 70 ml, "F4" Tubing Set, case of 24
ORIGEN BIOMEDICAL, INC.
CS250F4
Not in Commercial Distribution

  • 20816203020875 ()
  • 10816203020878 ()
  • 00816203020871 ()


  • Blood/tissue storage/culture container

Cryostore - 10816203020854

CryoStore multiple bag set, 10 x CS50 EVA freezing bags + 1 x CS750 EVA freezing bag, sterile
ORIGEN BIOMEDICAL, INC.
CS50V7
In Commercial Distribution

  • 10816203020854 ()


  • Blood/tissue storage/culture container

Cryostore - 10816203020823

CryoStore 250 EVA Freezing Bag, 30-70ml, "Standard" Tube Set
ORIGEN BIOMEDICAL, INC.
CS250
In Commercial Distribution

  • 20816203020820 ()
  • 10816203020823 ()
  • 00816203020826 ()
CS250

  • Blood/tissue storage/culture container

Cryostore - 10816203020809

CryoStore 2000 EVA Freezing Bag, 180-450ml, "N" Tube Set, double aseptically packed
ORIGEN BIOMEDICAL, INC.
CS2000NS
In Commercial Distribution

  • 10816203020809 ()
  • 20816203020806 ()
CS2000NS

  • Blood/tissue storage/culture container

Cryostore - 10816203020786

CryoStore 2000 EVA Freezing Bag, 180 - 450 ml, "N" tube set
ORIGEN BIOMEDICAL, INC.
CS2000N
In Commercial Distribution

  • 20816203020783 ()
  • 10816203020786 ()
  • 00816203020789 ()
CS2000N

  • Blood/tissue storage/culture container

Cryostore - 10816203020762

CryoStore 1000 EVA Freezing Bag, 3-bag Set, 120 - 275 ml, "V4" Tube Set, case of 8 sets
ORIGEN BIOMEDICAL, INC.
CS1000V4
Not in Commercial Distribution

  • 10816203020762 ()
  • 20816203020769 ()


  • Blood/tissue storage/culture container

Cryostore - 10816203020731

Cryostore 1000 EVA Freezing Bag, 120-275ml, "N" Tubing Set, double aseptically pouched, case of 12
ORIGEN BIOMEDICAL, INC.
CS1000NS
Not in Commercial Distribution

  • 10816203020731 ()
  • 20816203020738 ()


  • Blood/tissue storage/culture container

CryoStore - 10816203020717

Cryostore 250 EVA Freezing Bag, 30 - 70 ml, "F21" Tubing Set, with IBS and male luer cap, singly packed, case of 12
ORIGEN BIOMEDICAL, INC.
CS250F21P
Not in Commercial Distribution

  • 20816203020714 ()
  • 10816203020717 ()


  • Blood/tissue storage/culture container

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 - 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 - 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 - 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 - 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 - 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

TCD B40 Wafers - 10866305000278

The TCDB40 Wafer Assembly consists of a copper wafer and plastic holder. The plastic holder is color coded to assist the operator with proper placement/insertion. The wafer assembly is placed in the TCDB40 Sterile Tube Welding device prior to the weld process. The copper wafer is separated from the plastic holder during the welding process and after welding is completed both the plastic holder and the copper wafer are removed from the device and discarded. The wafers are single use only and cannot be reused. The TCDB40 Sterile Tube Welding device will not operate without a wafer assembly inserted and will not operate with a used a wafer. The TCDB40 wafer assemblies are packaged in 8 plastic trays. Each tray has 25 individual wafer assemblies. Each box referred to as a case has a total of 200 individual TCDB40 wafer assemblies.
GENESIS BPS LLC
TCD B40
In Commercial Distribution

  • 10866305000278 ()
  • 00866305000271 ()
480-B40-00-2038

  • Laboratory tubing welder

RapidWeld Blade Module Kit - 10866305000254

The Blade Module consists of a stainless steel blade that cuts the PVC tube segments. The Blade Module is designed with a built in service meter to record the number of welds performed on the device. This feature monitors the usage endured by the Blade Module. The operator is notified when the Blade Module requires replacement. If the operator fails to respond to the warning message and replace the Blade Module the Genesis Rapid Weld STW will not operate once the Blade Module weld cycle limit is reached. Operation will resume once a replacement Blade Module is installed.
GENESIS BPS LLC
GRW-430
In Commercial Distribution

  • 10866305000254 ()
  • 00866305000257 ()
480-RW-2478-03

  • Laboratory tubing welder

RapidWeld Blade Module Kit - 10866305000247

The Blade Module consists of a stainless steel blade that cuts the PVC tube segments. The Blade Module is designed with a built in service meter to record the number of welds performed on the device. This feature monitors the usage endured by the Blade Module. The operator is notified when the Blade Module requires replacement. If the operator fails to respond to the warning message and replace the Blade Module the Genesis Rapid Weld STW will not operate once the Blade Module weld cycle limit is reached. Operation will resume once a replacement Blade Module is installed.
GENESIS BPS LLC
GRW-430
In Commercial Distribution

  • 10866305000247 ()
  • 00866305000240 ()
480-RW-2478-02

  • Laboratory tubing welder

RapidWeld Blade Module Kit - 10866305000230

The Blade Module consists of a stainless steel blade that cuts the PVC tube segments. The Blade Module is designed with a built in service meter to record the number of welds performed on the device. This feature monitors the usage endured by the Blade Module. The operator is notified when the Blade Module requires replacement. If the operator fails to respond to the warning message and replace the Blade Module the Genesis RapidWeld STW, Model GRW-430 will not operate once the Blade Module weld cycle limit is reached. Operation will resume once a replacement Blade Module is installed.
GENESIS BPS LLC
GRW-430
In Commercial Distribution

  • 10866305000230 ()
  • 00866305000233 ()
480-RW-2478-01

  • Laboratory tubing welder
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