FDA.reportPublic FDA data

3ml Syringe, FLL X SCD

Primary DI
10816203020564
Brand
3ml Syringe, FLL X SCD
Company
ORIGEN BIOMEDICAL, INC.
Model
15-R3FT
Device description
3ml BD syringe on a female luer with 15cm of SCD tubing
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
20816203020561PackageGS125In Commercial Distribution
10816203020564PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2081620302056120816203020561
1081620302056410816203020564

GMDN Terms#

Term, Definition table
TermDefinition
Fluid transfer set, general-purposeA collection of devices and supplies designed to transfer several types of medical fluids (e.g., drugs, vaccines, blood, and solutions) between a first container(s) [e.g., a vial(s)] and a second container [e.g., an intravenous (IV) bag]; it is not dedicated to a particular type of fluid or clinical procedure. It is available in a variety of configurations and typically includes tubes, connectors, spike(s), syringes, and caps. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
512-474-7278regulatory@origen.com

Regulatory Flags#

DUNS number
625272232
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10816203023800AccessoriesIBSIBS2025-06-18
20816203023845AccessoriesVSVVSV2025-06-18
20816203023852Accessories15-R3FT15-R3FT2025-06-18
20816203023869Accessories15-R6F-TA15-R6F-TA2025-06-18
20816203023876Accessories15-RF12-T15-RF12-T2025-06-18
20816203023883Accessories15-RF20-T15-RF20-T2025-06-18
20816203023906CryoStore Freezing BagCS25FPCS25FP2025-06-18
20816203023913O-Wrap™ BagOW0909OW09092025-06-18
20816203023920PermaLife™ Cell Culture BagPL07-2GPL07-2G2025-06-18
20816203023937PermaLife™ Cell Culture BagPL30-2GPL30-2G2025-06-18
20816203023944AccessoriesR3F-T15R3F-T152025-06-18
20816203023968AccessoriesS-F10S-F102025-06-18
20816203023975AccessoriesS-F50S-F502025-06-18
20816203023982AccessoriesS-FFP12S-FFP122025-06-18
20816203023999AccessoriesS-M50S-M502025-06-18
20816203024019TissueVault™ Cell & Tissue Freezing BagTV0909TV09092025-06-18
20816203024057CryoStore Freezing BagCS25Y4CS25Y42025-06-18
20816203024064CryoStore Freezing BagCS28VCS28V2025-06-18
20816203024071Evolve Cell Culture BagEV120 + F-M12EV120 + F-M122025-06-18
20816203024095O-Wrap™ BagOW0918OW09182025-06-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
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00810180841757LabChoice Plastic Test Tubes, Polypropylene, 13 x 75 mm Dynarex CorporationKJG2025-04-17
00810180841764LabChoice Plastic Test Tubes, Polystyrene, 13 x 100 mm Dynarex CorporationKJG2025-04-17
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00810180841788LabChoice Plastic Test Tubes, Polypropylene, 16 x 100 mm Dynarex CorporationKJG2025-04-17
00810180841795LabChoice Plastic Test Tubes, Polypropylene, 13 x 100 mm Dynarex CorporationKJG2025-04-17
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00810180841238LabChoice Glass Test Tubes, 12 x 75 mm Dynarex CorporationKJG2025-03-05
00810180841245LabChoice Glass Test Tubes, 13 x 100 mm Dynarex CorporationKJG2025-03-05
00810180841252LabChoice Glass Test Tubes, 16 x 100 mm Dynarex CorporationKJG2025-03-05
00810180841153LabChoice Tubes, With Dual Position Cap, Polystyrene Peel Pack, 17 x 100 mm Dynarex CorporationKJG2025-03-03
00810180841122LabChoice Culture Tubes,With Dual Position Cap, Polystyrene Peel Pack,12 x 75mmDynarex CorporationKJG2025-03-03
00810180841160LabChoice Culture Tubes,With Dual Position Cap, Polystyrene Peel Pack Dynarex CorporationKJG2025-03-03