TEG5000 Hemostasis System
Plateletmapping Multipak ADP & AA
1manufacturer
3catalogue numbers in this listing
Who Else Makes It
Registered in Zhejiang. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Gongdong Medical Technology Co., Ltd. | Taizhou | Zhejiang | Contract manufacturer | 40 |
Record
| Listed by | Haemonetics Corporation, United States |
|---|---|
| FDA product code | JOZ |
| Device type | System, Automated Platelet Aggregation |
| Device class | Class 2 |
| Regulation | 21 CFR 864.5700 |
| Establishment | Specification developer, Manufacturer, Exporter |
| 510(k) | K041502 |
| Record published | 2017-04-25 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 2 to 8 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 07-042 | In distribution | |
| 07-040 | In distribution | |
| 07-041 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| VerifyNow System | Accriva Diagnostics, Inc. | 12 |
| Chrono-log | Chrono-LOG Corp. | 10 |
| TEG6s Hemostasis System | Haemonetics Corporation | 5 |
| VerifyNow Platelet Reactivity Test | Accriva Diagnostics, Inc. | 4 |
| TEG Hemostasis System | Haemonetics Corporation | 3 |
| AggRecetin | Bio/Data Corp. | 2 |
| Aggreguide | Aggredyne, Inc. | 2 |
| Plateletworks Combo-25 Kit | Helena Laboratories, Corp. | 1 |
| Epinephrine | Bio/Data Corp. | 1 |
| Bapa tube | Zacros Corporation | 1 |
| T-TAS 01 Total Thrombus Formation Analysis System | Zacros Corporation | 1 |
| PL Chip for T-TAS 01 | Zacros Corporation | 1 |
Showing 12 of 34. All products under System, Automated Platelet Aggregation
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.