FDA.reportPublic FDA data

Accessories

Primary DI
10816203023800
Brand
Accessories
Company
ORIGEN BIOMEDICAL, INC.
Model
IBS
Catalog number
IBS
Device description
DMSO-Resistant Bag Spike with needle injection port
Published
2025-06-18
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KJGTube, Tissue Culture

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KJGTube, Tissue CulturePathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20816203023807PackageGS150In Commercial Distribution
10816203023800PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2081620302380720816203023807
1081620302380010816203023800

GMDN Terms#

Term, Definition table
TermDefinition
Blood transfer setA collection of sterile, flexible, plastic tubing and associated items (e.g., couplers, adapters, clamps) used to transfer blood or blood components (e.g., peripheral stem cells, plasma) into containers or between containers for processing or storage (e.g., freezing). This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Do not re-use
Special Storage Condition, Specify00Do not resterilize
Special Storage Condition, Specify00Do not use if package is damaged
Special Storage Condition, Specify00Keep Dry

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1-512-474-7278regulatory@origenbio.com

Regulatory Flags#

DUNS number
625272232
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10816203023848AccessoriesVSVVSV2025-06-18
10816203023916O-Wrap™ BagOW0909OW09092025-06-18
10816203024012TissueVault™ Cell & Tissue Freezing BagTV0909TV09092025-06-18
10816203024074Evolve Cell Culture BagEV120 + F-M12EV120 + F-M122025-06-18
10816203024098O-Wrap™ BagOW0918OW09182025-06-18
10816203024159TissueVault™ Cell & Tissue Freezing BagTV0918TV09182025-06-18
10816203023923PermaLife™ Cell Culture BagPL07-2GPL07-2G2025-06-18
10816203023930PermaLife™ Cell Culture BagPL30-2GPL30-2G2025-06-18
10816203024104PermaLife™ Cell Culture BagPL30MPL30M2025-06-18
10816203024128PermaLife™ Cell Culture BagPL70-2GPL70-2G2025-06-18
10816203024340PermaLife™ Cell Culture BagPL120NPL120N2025-06-18
10816203024357PermaLife™ Cell Culture BagPL120-2GPL120-2G2025-06-18
10816203023855Accessories15-R3FT15-R3FT2025-06-18
10816203023862Accessories15-R6F-TA15-R6F-TA2025-06-18
10816203023879Accessories15-RF12-T15-RF12-T2025-06-18
10816203023886Accessories15-RF20-T15-RF20-T2025-06-18
10816203023947AccessoriesR3F-T15R3F-T152025-06-18
10816203023961AccessoriesS-F10S-F102025-06-18
10816203023978AccessoriesS-F50S-F502025-06-18
10816203023985AccessoriesS-FFP12S-FFP122025-06-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
20197344203342MEDLINEMEDLINE INDUSTRIES, INC.KJG2026-04-27
20197344203359MEDLINEMEDLINE INDUSTRIES, INC.KJG2026-04-27
10816203023848AccessoriesORIGEN BIOMEDICAL, INC.KJG2025-06-18
10816203023855AccessoriesORIGEN BIOMEDICAL, INC.KJG2025-06-18
10816203023862AccessoriesORIGEN BIOMEDICAL, INC.KJG2025-06-18
10816203023879AccessoriesORIGEN BIOMEDICAL, INC.KJG2025-06-18
10816203023886AccessoriesORIGEN BIOMEDICAL, INC.KJG2025-06-18
10816203023947AccessoriesORIGEN BIOMEDICAL, INC.KJG2025-06-18
10816203023961AccessoriesORIGEN BIOMEDICAL, INC.KJG2025-06-18
10816203023978AccessoriesORIGEN BIOMEDICAL, INC.KJG2025-06-18
10816203023985AccessoriesORIGEN BIOMEDICAL, INC.KJG2025-06-18
10816203023992AccessoriesORIGEN BIOMEDICAL, INC.KJG2025-06-18
10816203024142AccessoriesORIGEN BIOMEDICAL, INC.KJG2025-06-18
10816203024333AccessoriesORIGEN BIOMEDICAL, INC.KJG2025-06-18
20816203023845AccessoriesORIGEN BIOMEDICAL, INC.KJG2025-06-18
20816203023852AccessoriesORIGEN BIOMEDICAL, INC.KJG2025-06-18
20816203023869AccessoriesORIGEN BIOMEDICAL, INC.KJG2025-06-18
20816203023876AccessoriesORIGEN BIOMEDICAL, INC.KJG2025-06-18
20816203023883AccessoriesORIGEN BIOMEDICAL, INC.KJG2025-06-18
20816203023944AccessoriesORIGEN BIOMEDICAL, INC.KJG2025-06-18
20816203023968AccessoriesORIGEN BIOMEDICAL, INC.KJG2025-06-18
20816203023975AccessoriesORIGEN BIOMEDICAL, INC.KJG2025-06-18
20816203023982AccessoriesORIGEN BIOMEDICAL, INC.KJG2025-06-18
20816203023999AccessoriesORIGEN BIOMEDICAL, INC.KJG2025-06-18
20816203024149AccessoriesORIGEN BIOMEDICAL, INC.KJG2025-06-18
10816203024180AccessoriesORIGEN BIOMEDICAL, INC.KJG2025-06-18
10816203024197AccessoriesORIGEN BIOMEDICAL, INC.KJG2025-06-18
20816203024330AccessoriesORIGEN BIOMEDICAL, INC.KJG2025-06-18
00840117336544LabChoice Plastic Test Tubes, Polystyrene, 12 x 75 mm Dynarex CorporationKJG2025-04-17
00840117336551LabChoice Plastic Test Tubes, Polypropylene, 12 x 75 mm Dynarex CorporationKJG2025-04-17