Primary Device ID | 10816203022469 |
NIH Device Record Key | 5508e798-c36d-4bd9-8668-99d797409ae9 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Spike Adapter |
Version Model Number | S-M50C |
Company DUNS | 625272232 |
Company Name | ORIGEN BIOMEDICAL, INC. |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | true |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | true |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | false |
Expiration Date | true |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Phone | 512-474-7278 |
regulatory@origen.com | |
Phone | 512-474-7278 |
regulatory@origen.com | |
Phone | 512-474-7278 |
regulatory@origen.com | |
Phone | 512-474-7278 |
regulatory@origen.com | |
Phone | 512-474-7278 |
regulatory@origen.com | |
Phone | 512-474-7278 |
regulatory@origen.com | |
Phone | 512-474-7278 |
regulatory@origen.com | |
Phone | 512-474-7278 |
regulatory@origen.com | |
Phone | 512-474-7278 |
regulatory@origen.com | |
Phone | 512-474-7278 |
regulatory@origen.com | |
Phone | 512-474-7278 |
regulatory@origen.com | |
Phone | 512-474-7278 |
regulatory@origen.com | |
Phone | 512-474-7278 |
regulatory@origen.com | |
Phone | 512-474-7278 |
regulatory@origen.com | |
Phone | 512-474-7278 |
regulatory@origen.com | |
Phone | 512-474-7278 |
regulatory@origen.com | |
Phone | 512-474-7278 |
regulatory@origen.com | |
Phone | 512-474-7278 |
regulatory@origen.com | |
Phone | 512-474-7278 |
regulatory@origen.com | |
Phone | 512-474-7278 |
regulatory@origen.com | |
Phone | 512-474-7278 |
regulatory@origen.com | |
Phone | 512-474-7278 |
regulatory@origen.com | |
Phone | 512-474-7278 |
regulatory@origen.com | |
Phone | 512-474-7278 |
regulatory@origen.com | |
Phone | 512-474-7278 |
regulatory@origen.com |
Device Issuing Agency | Device ID |
---|---|
GS1 | 10816203022469 [Primary] |
GS1 | 20816203022466 [Package] Package: Case [24 Units] In Commercial Distribution |
KJG | Tube, Tissue Culture |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 3 |
Public Version Date | 2021-02-19 |
Device Publish Date | 2016-09-23 |
10816203022469 | One spike to one male luer with 50cm DMSO resistant tubing and pinch clamp, case of 50 |
10816203022384 | One spike to one spike with 10cm of SCD tubing and pinch clamp, case of 50 |
10816203021967 | One spike with male to male luer, case of 50 |
10816203021936 | One spike to one spike with 50cm of SCD tubing and pinch clamp, case of 50 |
10816203021929 | One spike to one female luer with 15cm DMSO resistant tubing and pinch clamp, case of 50 |
10816203021912 | One spike to one 3/8" barb with 12cm DMSO resistant tubing |
10816203020588 | One spike to one male luer with 150cm tubing and roller clamp |
10816203020274 | One spike to 1 male luer w/50cm SCD tubing & roller clamp |
20816203020264 | One spike to one male luer with 50cm DMSO resistant tubing and pinch clamp, case of 50 |
10816203020250 | One spike to one male luer with 10cm DMSO resistant tubing and pinch clamp, case of 50 |
10816203020243 | One spike to one female luer with 50cm DMSO resistant tubing and pinch clamp, case of 50 |
10816203020236 | One spike to one female luer with 10cm DMSO resistant tubing and pinch clamp, case of 50 |
10816203020632 | One spike to a needle-free valve to one spike and two male luers with 40cm tubing and roller cla |