Curaplex
*CUSTOM* Shelby Co Blood Draw Kit
1manufacturer
1catalogue number
Who Else Makes It
Registered in Zhejiang.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hantech Medical Device Co., Ltd. | Cixi | Zhejiang | Contract manufacturer | 18 |
Record
| Listed by | Bound Tree Medical, LLC, United States |
|---|---|
| FDA product code | CBT |
| Device type | Arterial Blood Sampling Kit |
| Device class | Class 1 |
| Regulation | 21 CFR 868.1100 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-12-15 |
| Record revised | 2022-08-16 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Packaging | Case of 50 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 8600-01331 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Pulset | Westmed, Inc. | 49 |
| Medline | Medline Industries, Inc. | 24 |
| Centurion | Centurion Medical Products Corporation | 22 |
| Medex | ICU Medical, Inc | 22 |
| Regard™ | Resource Optimization & Innovation, L.L.C. | 16 |
| AirLife™ | Airlife, Inc. | 16 |
| Deltran | Utah Medical Products, Inc. | 14 |
| A-Line | Westmed, Inc. | 12 |
| Pulset | SunMed Group Holdings, LLC | 11 |
| Atellica® VTR Syringes | SunMed Group Holdings, LLC | 7 |
| Blood Gas Sampler | Westmed, Inc. | 7 |
| Atellica® VTR Syringes | Westmed, Inc. | 5 |
Showing 12 of 41. All products under Arterial Blood Sampling Kit
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.