Primary Device ID | 20613994923282 |
NIH Device Record Key | a5642e33-e8a9-409c-a8b0-3f67c6acab26 |
Commercial Distribution Status | In Commercial Distribution |
Version Model Number | 306-01POR |
Company DUNS | 006261481 |
Company Name | MEDTRONIC, INC. |
Device Count | 10 |
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 *Lyophilized Heparin Assay Controls must be refrigerated (2°C to 10°C) until use. Once reconstituted, controls are stable for 2 hours at refrigerated or room temperature (2°C to 25°C). |
Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Lyophilized Heparin Assay Controls must be refrigerated (2°C to 10°C) until use. Once reconstituted, controls are stable for 2 hours at refrigerated or room temperature (2°C to 25°C). |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00613994923288 [Unit of Use] |
GS1 | 20613994923282 [Primary] |
JOX | ANALYZER, HEPARIN, AUTOMATED |
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 | 2016-06-18 |
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00763000984021 - NA | 2024-11-15 CUSTOM PACK BB12H36R4 PUMP TABLE |
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00763000984168 - NA | 2024-11-15 CUSTOM PACK BB12F26R4 MUNSTER FUS |
00763000984175 - NA | 2024-11-15 CUSTOM PACK BB12F66R6 1/4 EC PACK |