Primary Device ID | 00813153025000 |
NIH Device Record Key | 5d719cde-75bf-4414-8181-bafaeac47b9e |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Walrus by CODAN |
Version Model Number | A 817-W |
Company DUNS | 058027475 |
Company Name | Codan US Corporation |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
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 | true |
Expiration Date | true |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | true |
RX Perscription | false |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00813153025000 [Package] Contains: 10813153025007 Package: Multivac packaging [1 Units] In Commercial Distribution |
GS1 | 10813153025007 [Primary] |
FPA | Set, Administration, Intravascular |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2025-06-09 |
Device Publish Date | 2025-05-30 |
00813153027882 - LABEL PRODUCT -CODAN | 2025-09-04 Extension Set with 1.2-micron Filter |
00813153027936 - LABEL PRODUCT -CODAN | 2025-09-04 Blood Transfer Set |
00813153027967 - Kabi Access Infusion Sets | 2025-09-04 Stopcock 4-way stopcock with rotating Luer-lock |
00813153027981 - Kabi Access Infusion Sets | 2025-09-04 Short Extension Set T-Connector |
00813153028001 - Kabi Access Infusion Sets | 2025-09-04 Manifold 2 Port 4-way stopcocks and rotating male Luer-lock |
00813153028018 - Kabi Access Infusion Sets | 2025-09-04 Manifold 4 Port 4-way Stopcocks on a manifold plate |
00813153028025 - LABEL PRODUCT -CODAN | 2025-09-04 Vented Transfer Set with Female Luer-lock |
00813153027929 - LABEL PRODUCT -CODAN | 2025-09-04 Neonatal Blood Administration Set with Filter & 30cc Syringe |