Manifold Set

GUDID 10816203020038

Four spikes to four male luers with 60cm SCD tubing, roller and pinch clamps

ORIGEN BIOMEDICAL, INC.

Blood transfer set
Primary Device ID10816203020038
NIH Device Record Keyc78e3024-2e23-4eca-b81b-58e4a297566f
Commercial Distribution StatusIn Commercial Distribution
Brand NameManifold Set
Version Model Number4S-4M60
Company DUNS625272232
Company NameORIGEN BIOMEDICAL, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone512-474-7278
Emailregulatory@origen.com
Phone512-474-7278
Emailregulatory@origen.com
Phone512-474-7278
Emailregulatory@origen.com
Phone512-474-7278
Emailregulatory@origen.com
Phone512-474-7278
Emailregulatory@origen.com
Phone512-474-7278
Emailregulatory@origen.com
Phone512-474-7278
Emailregulatory@origen.com
Phone512-474-7278
Emailregulatory@origen.com
Phone512-474-7278
Emailregulatory@origen.com
Phone512-474-7278
Emailregulatory@origen.com
Phone512-474-7278
Emailregulatory@origen.com
Phone512-474-7278
Emailregulatory@origen.com
Phone512-474-7278
Emailregulatory@origen.com

Device Identifiers

Device Issuing AgencyDevice ID
GS110816203020038 [Primary]
GS120816203020035 [Package]
Package: Case [12 Units]
In Commercial Distribution

FDA Product Code

KJGTube, Tissue Culture

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2025-06-18
Device Publish Date2016-09-23

On-Brand Devices [Manifold Set]

10816203021950One spike, vented drip chamber to 9 male luers w/140cm SCD tubing, pinch clamps
10816203020038Four spikes to four male luers with 60cm SCD tubing, roller and pinch clamps

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