Accessory Set

GUDID 20816203022435

Spike port to six male luers. Singly pouched, 12 per case.

ORIGEN BIOMEDICAL, INC.

Blood transfer set
Primary Device ID20816203022435
NIH Device Record Keyfa70dca5-65a3-43d4-a05b-add740c41554
Commercial Distribution Discontinuation2024-12-11
Commercial Distribution StatusNot in Commercial Distribution
Brand NameAccessory Set
Version Model Number30-P-6M
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

Device Identifiers

Device Issuing AgencyDevice ID
GS110816203022438 [Primary]
GS120816203022435 [Package]
Contains: 10816203022438
Package: Case [12 Units]
Discontinued: 2024-12-11
Not 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 Date2024-12-12
Device Publish Date2016-09-23

On-Brand Devices [Accessory Set]

20816203023265Two spikes to nine male luers with 140cm SCD tubing and pinch clamps
20816203023197One female luer to 9 male luers, 45cm PVC tubing, with pinch clamps
20816203022435Spike port to six male luers. Singly pouched, 12 per case.

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