Primary Device ID | 07640135140825 |
NIH Device Record Key | ea895df3-a40d-4d2c-b86f-15cf2b74d0b9 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | CMAG TRANSPORTER, SPARE PART KIT |
Version Model Number | 201-50147 |
Catalog Number | 201-50147 |
Company DUNS | 486066918 |
Company Name | Thoratec Switzerland GmbH |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | true |
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 | 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 | false |
OTC Over-The-Counter | false |
Phone | +1(855)478-5833 |
customerservice@sjm.com |
Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 110 KiloPascal |
Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 110 KiloPascal |
Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 110 KiloPascal |
Device Issuing Agency | Device ID |
---|---|
GS1 | 07640135140825 [Primary] |
KFM | Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type |
KRI | ACCESSORY EQUIPMENT, CARDIOPULMONARY BYPASS |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 8 |
Public Version Date | 2019-10-04 |
Device Publish Date | 2014-09-20 |
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