Primary Device ID | 00643169272248 |
NIH Device Record Key | f8a51b6b-7ce5-4404-9da4-bf975bf40b7c |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Affinity™ |
Version Model Number | AP40AST |
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 | false |
Lot Batch | false |
Serial Number | true |
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 | |
Phone | +1(800)633-8766 |
Corporate.UDI@medtronic.com | |
Phone | +1(800)633-8766 |
Corporate.UDI@medtronic.com |
Special Storage Condition, Specify | Between 0 and 0 *Avoid storing the adapter in direct sunlight. |
Special Storage Condition, Specify | Between 0 and 0 *Do not store at extremes of temperature and humidity. |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106.3 KiloPascal |
Storage Environment Temperature | Between -30 Degrees Celsius and 70 Degrees Celsius |
Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
Special Storage Condition, Specify | Between 0 and 0 *Avoid storing the adapter in direct sunlight. |
Special Storage Condition, Specify | Between 0 and 0 *Do not store at extremes of temperature and humidity. |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106.3 KiloPascal |
Storage Environment Temperature | Between -30 Degrees Celsius and 70 Degrees Celsius |
Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
Special Storage Condition, Specify | Between 0 and 0 *Avoid storing the adapter in direct sunlight. |
Special Storage Condition, Specify | Between 0 and 0 *Do not store at extremes of temperature and humidity. |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106.3 KiloPascal |
Storage Environment Temperature | Between -30 Degrees Celsius and 70 Degrees Celsius |
Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
Special Storage Condition, Specify | Between 0 and 0 *Avoid storing the adapter in direct sunlight. |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00643169272248 [Primary] |
KFM | Pump, blood, cardiopulmonary bypass, non-roller type |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2019-06-17 |
Device Publish Date | 2019-06-09 |
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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 |