Primary Device ID | 20643169767748 |
NIH Device Record Key | 6611b225-1a19-4ea2-ab41-5a2a92ebbe1f |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Affinity™ |
Version Model Number | 61399409503 |
Company DUNS | 006261481 |
Company Name | MEDTRONIC, INC. |
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 | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Phone | +1(800)633-8766 |
Corporate.UDI@medtronic.com | |
Phone | +1(800)633-8766 |
Corporate.UDI@medtronic.com |
Pore Size | 20 Micrometer |
Pore Size | 20 Micrometer |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00643169767737 [Primary] |
GS1 | 20643169767748 [Package] Contains: 00643169767737 Package: PK [6 Units] In Commercial Distribution |
DTM | Filter, blood, cardiopulmonary bypass, arterial line |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 3 |
Public Version Date | 2018-07-06 |
Device Publish Date | 2017-01-21 |
20643169878116 | FILTER CB851 AF100 WITH CORTIVA 26L |
20643169858910 | FILTER S4014 AFFINITYPEDIATRIC ART ST |
20643169858842 | FILTER 61399409434 AFFINITY 6PK ARFIL20M |
20643169858835 | FILTER 61399401124 AFFINITY 6PK ART 351 |
20643169767762 | FILTER 61399401153 AFFINITY 6CA ART 352 |
20643169767748 | FILTER 61399409503 AFFINITY ART 354 6PK |
00643169745001 | HANDCRANK HC150A |
00763000219628 | PROBE ATP210 AFFINITY TEMPERATURE |
00643169272248 | ADAPTER AP40AST AFFINITY CP WW |
00763000301330 | HANDCRANK HC150A PLX 31L |
20763000134567 | PUMP CBAP40 AFFINITY CP CENTRIFUGAL CC |
20763000134550 | PUMP BBAP40 AFFINITY CP CENTRIFUGAL BC |
20763000134536 | PUMP AP40 AFFINITY CP CENTRIFUGAL NC |
00763000445744 | FINAL PACK ATP210 TEMP PROBE GBL |