Primary Device ID | 50699753450788 |
NIH Device Record Key | 483cb5ec-5bc5-4bea-8f2c-2d00ee06d78a |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Capiox® FX Advance Hollow Fiber Oxygenator w Integrated AF w Hardshell Res. |
Version Model Number | 3CX*FX15RW30C |
Company DUNS | 177655466 |
Company Name | Terumo Cardiovascular Systems 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 | 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 |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00699753450783 [Primary] |
GS1 | 50699753450788 [Package] Contains: 00699753450783 Package: 4 Piece Case [4 Units] In Commercial Distribution |
DTN | Reservoir, Blood, Cardiopulmonary Bypass |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 4 |
Public Version Date | 2020-01-22 |
Device Publish Date | 2016-01-20 |
50699753450832 | 3CX*FX25RWC |
50699753450825 | 3CX*FX25REC |
50699753450818 | 3CX*FX15RE40C |
50699753450801 | 3CX*FX15RE30C |
50699753450795 | 3CX*FX15RW40C |
50699753450788 | 3CX*FX15RW30C |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() CAPIOX 74561748 1957236 Live/Registered |
TERUMO KABUSHIKI KAISHA 1994-08-16 |
![]() CAPIOX 73401694 1295899 Dead/Cancelled |
Terumo Kabushiki Kaisha 1982-11-04 |