Primary Device ID | 00643169272231 |
NIH Device Record Key | 150bb2ce-b383-44a5-a02d-fffedb8b862d |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Affinity™ CP |
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 | |
Phone | +1(800)633-8766 |
Corporate.UDI@medtronic.com |
Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -30 Degrees Celsius and 70 Degrees Celsius |
Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106.3 KiloPascal |
Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -30 Degrees Celsius and 70 Degrees Celsius |
Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106.3 KiloPascal |
Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -30 Degrees Celsius and 70 Degrees Celsius |
Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106.3 KiloPascal |
Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00643169272231 [Primary] |
KFM | PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 4 |
Public Version Date | 2019-05-31 |
Device Publish Date | 2014-09-23 |
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