FDA.reportPublic FDA data

Accessories

Primary DI
10816203023992
Brand
Accessories
Company
ORIGEN BIOMEDICAL, INC.
Model
S-M50
Catalog number
S-M50
Device description
One spike to one male luer with 50cm SCD tubing and pinch clamp
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
20816203023999PackageGS150Not in Commercial Distribution
10816203023992PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2081620302399920816203023999
1081620302399210816203023992

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

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
10816203021721Percutaneous KitPCTa2016-09-23
10816203023145Percutaneous TrayPCT2016-11-28
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

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
10816203024142AccessoriesORIGEN BIOMEDICAL, INC.KJG2025-06-18
10816203024333AccessoriesORIGEN BIOMEDICAL, INC.KJG2025-06-18
10816203023800AccessoriesORIGEN 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