Primary Device ID | 07640135140078 |
NIH Device Record Key | 2630d54c-2b69-45c9-b326-ea9c84f4b91e |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | CENTRIMAG MOTOR |
Version Model Number | 102956 |
Catalog Number | 102956 |
Company DUNS | 486066918 |
Company Name | Thoratec Switzerland GmbH |
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 | true |
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(855)478-5833 |
customerservice@sjm.com |
Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 79.3 KiloPascal and 101.3 KiloPascal |
Device Issuing Agency | Device ID |
---|---|
GS1 | 07640135140078 [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 | 5 |
Public Version Date | 2019-01-31 |
Device Publish Date | 2014-09-20 |
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