N/A
- Primary DI
- 00643169730151
- Brand
- N/A
- Company
- MEDTRONIC, INC.
- Model
- 304-20POR
- Device description
- CRTG 304-20POR PORC HDR 5L INT 9BX
- Published
- 2021-11-12
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- false
- OTC
- false
- Sterile
- false
- Single use
- true
Product Codes
| Code | Name |
|---|
| JBP | ACTIVATED WHOLE BLOOD CLOTTING TIME |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| JBP | Activated Whole Blood Clotting Time | Hematology | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 20643169730155 | Primary | GS1 | 0 | |
| 00643169730151 | Unit of Use | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|
| 20643169730155 | 20643169730155 | | |
| 00643169730151 | 00643169730151 | 643169730151 | 0643169730151 |
GMDN Terms
| Term | Definition |
|---|
| Heparin anti-Xa IVD, kit, chromogenic | A collection of reagents and other associated materials intended to be used for the quantitative detection of heparin by measuring its ability to inhibit the activity of activated factor X (factor Xa) in a clinical specimen, using a chromogenic method. The assay is typically used to monitor anticoagulation therapy. |
Storage And Handling
| Type | Low | High | Condition |
|---|
| Special Storage Condition, Specify | 0 | 0 | Refrigerated 2°C-10°C |
| Special Storage Condition, Specify | 0 | 0 | Room Temperature 10°C-25°C |
Regulatory Flags
- DUNS number
- 006261481
- Device count
- 9
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
Other Devices From This Company
Other Devices Sharing Product Codes
| Primary DI | Brand | Company | Product code | Published |
|---|
| 20763000558332 | HR HTC | MEDTRONIC, INC. | JBP | 2026-02-23 |
| 20763000558196 | CLOTtrac™ | MEDTRONIC, INC. | JBP | 2026-02-22 |
| 20763000558202 | CLOTtrac™ | MEDTRONIC, INC. | JBP | 2026-02-22 |
| 20763000558219 | CLOTtrac™ | MEDTRONIC, INC. | JBP | 2026-02-22 |
| 20763000558226 | CLOTtrac™ | MEDTRONIC, INC. | JBP | 2026-02-22 |
| 20763000558233 | CLOTtrac™ | MEDTRONIC, INC. | JBP | 2026-02-22 |
| B558DP29510 | Sonoclot® Coagulation & Platelet Function Analyzer | SIENCO, INC. | JBP | 2023-06-28 |
| 00763000433819 | LR-ACT | MEDTRONIC, INC. | JBP | 2023-04-08 |
| 00763000433840 | HR-ACT | MEDTRONIC, INC. | JBP | 2023-04-08 |
| 00763000441456 | NA | MEDTRONIC, INC. | JBP | 2023-04-07 |
| 00711234103404 | GEM Hemochron 100 Activated Clotting Time Plus Test (ACT+) | ACCRIVA DIAGNOSTICS HOLDINGS, INC. | JBP | 2022-01-21 |
| 00711234103411 | GEM Hemochron 100 Low Range Activated Clotting Time Test (ACT-LR) | ACCRIVA DIAGNOSTICS HOLDINGS, INC. | JBP | 2022-01-21 |
| B55880004410 | Sonoclot® aiACT Kit | SIENCO, INC. | JBP | 2021-07-19 |
| B55880004420 | Sonoclot® aiACT Kit | SIENCO, INC. | JBP | 2021-07-19 |
| B55880004110 | Sonoclot® gbACT+ Kit | SIENCO, INC. | JBP | 2021-05-26 |
| B55880004120 | Sonoclot® gbACT+ Kit | SIENCO, INC. | JBP | 2021-05-26 |
| 20763000014845 | CLOTtrac™ | MEDTRONIC, INC. | JBP | 2018-05-26 |
| 20763000014852 | CLOTtrac™ | MEDTRONIC, INC. | JBP | 2018-05-25 |
| 20763000014821 | CLOTtrac™ | MEDTRONIC, INC. | JBP | 2018-05-06 |
| 20763000014838 | CLOTtrac™ | MEDTRONIC, INC. | JBP | 2018-05-06 |
| 20763000014869 | CLOTtrac™ | MEDTRONIC, INC. | JBP | 2018-05-06 |
| 20812747018088 | TEG5000 HEMOSTASIS SYSTEM | HAEMONETICS CORPORATION | JBP | 2017-04-21 |
| 20643169713264 | NA | MEDTRONIC, INC. | JBP | 2016-09-25 |
| 20613994417293 | HR-ACT | MEDTRONIC, INC. | JBP | 2016-09-23 |
| 10711234101094 | Hemochron Whole Blood Coagulation System | ACCRIVA DIAGNOSTICS HOLDINGS, INC. | JBP | 2016-09-22 |
| 10711234101384 | Hemochron Whole Blood Coagulation System | ACCRIVA DIAGNOSTICS HOLDINGS, INC. | JBP | 2016-09-22 |
| 10711234101391 | Hemochron Whole Blood Coagulation System | ACCRIVA DIAGNOSTICS HOLDINGS, INC. | JBP | 2016-09-22 |
| 10711234103081 | Hemochron Whole Blood Microcoagulation System | ACCRIVA DIAGNOSTICS HOLDINGS, INC. | JBP | 2016-09-22 |
| 10054749000149 | i-STAT | ABBOTT POINT OF CARE INC. | JBP | 2016-09-09 |
| 10054749000156 | i-STAT | ABBOTT POINT OF CARE INC. | JBP | 2016-09-09 |
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