Primary Device ID | 20613994130383 |
NIH Device Record Key | 5837fa14-dcdf-471f-ac4e-ec3bfef66aa2 |
Commercial Distribution Status | In Commercial Distribution |
Version Model Number | 550-13 |
Company DUNS | 006261481 |
Company Name | MEDTRONIC, INC. |
Device Count | 30 |
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 | false |
OTC Over-The-Counter | false |
Phone | +1(800)633-8766 |
Corporate.UDI@medtronic.com | |
Phone | +1(800)633-8766 |
Corporate.UDI@medtronic.com |
Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Upon receipt, the control should be stored refrigerated, from 2° to 10°C, until use. Once reconstituted, the control is stable for 2 hours at room temperature, 15° to 25°C. |
Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Upon receipt, the control should be stored refrigerated, from 2° to 10°C, until use. Once reconstituted, the control is stable for 2 hours at room temperature, 15° to 25°C. |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00613994130389 [Unit of Use] |
GS1 | 20613994130383 [Primary] |
JPA | SYSTEM, MULTIPURPOSE FOR IN VITRO COAGULATION STUDIES |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 3 |
Public Version Date | 2018-07-06 |
Device Publish Date | 2016-07-17 |
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