Centurion
Compass Universalhg
7manufacturers in China registered for this device type
23catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Guangdong (5), Zhejiang (1), Shandong (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amphenol Medical Technologies (Dongguan) Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 77 |
| Bioxin Medical Co., Ltd. | Weihai | Shandong | Contract manufacturer | 8 |
| Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | Shenzhen | Guangdong | Specification developer | 61 |
| Orantech Inc. | Shenzhen | Guangdong | Contract manufacturer | 40 |
| Zhejiang Haisheng Medical Device Co., Ltd. | Shaoxing | Zhejiang | Contract manufacturer | 21 |
| Unimed Medical Supplies Inc | Shenzhen | Guangdong | Contract manufacturer | 15 |
| Shenzhen Antmed Co., Ltd. | Dongguan | Guangdong | Manufacturer | 4 |
Record
| Listed by | Centurion Medical Products Corporation, United States |
|---|---|
| FDA product code | DRS |
| Device type | Transducer, Blood-Pressure, Extravascular |
| Device class | Class 2 |
| Regulation | 21 CFR 870.2850 |
| Record published | 2016-09-10 |
| Record revised | 2018-10-31 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Packaging | Case of 5, box of 5, box of 10, case of 10 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| CLPH2O001-5 | In distribution | |
| CLPH2O001-5QB | In distribution | |
| CUHG1-INT | In distribution | |
| CUHG1-5KT | In distribution | |
| CUHG1-5QB | In distribution | |
| CCTP001 | In distribution | |
| CWHG001-5 | In distribution | |
| CGP001 | In distribution | |
| CVAHG001-5 | In distribution | |
| CTHR002-5QB | In distribution | |
| CCMP001-5 | In distribution | |
| CTHR002-5 | In distribution | |
| CUHG1-5 | In distribution | |
| CVAHG001 | In distribution | |
| CCT001 | In distribution | |
| CLCK001-5 | In distribution | |
| CTHR002-INT | In distribution | |
| CLCK001 | In distribution | |
| CGP002 | In distribution | |
| CTHR002 | In distribution | |
| CCMP001 | In distribution | |
| CLPH2O001-INT | In distribution | |
| CLPH2O001 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| ICU Medical | ICU Medical, Inc | 381 |
| Medex | ICU Medical, Inc | 225 |
| Biotrans™ Pressure Monitoring Kits | Bioptimal International Pte. Ltd. | 134 |
| Transpac™ | ICU Medical, Inc | 117 |
| Antmed | Shenzhen Antmed Co., Ltd. | 96 |
| Namic | Navilyst Medical, Inc. | 60 |
| Namic | Medline Industries, Inc. | 58 |
| Transpac™/Transtar™ | ICU Medical, Inc | 58 |
| Merit Medical® | Argon Critical Care Systems Singapore PTE. Ltd. | 28 |
| Transducer, Blood-Pressure, Extravascular | Utah Medical Products, Inc. | 22 |
| Deltran | Utah Medical Products, Inc. | 22 |
| Unimed | Unimed Medical Supplies Inc | 17 |
Showing 12 of 145. All products under Transducer, Blood-Pressure, Extravascular
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K161408 | 2016-11-22 |
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.