Safewedge(TM) Relief Valve Device
Catalogue number Safetywedge, listed by Bioptimal International Pte. Ltd., Singapore, under Probe, Thermodilution. 3 manufacturers in China are registered for this product code.
3manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Guangdong (1), Jiangsu (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 |
| GE Medical Systems (China) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 57 |
Record
| Listed by | Bioptimal International Pte. Ltd., Singapore |
|---|---|
| FDA product code | KRB |
| Device type | Probe, Thermodilution |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1915 |
| Establishment | Manufacturer |
| Record published | 2026-05-20 |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Special storage condition: Store in dark cool dry places |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Safetywedge | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| VolumeView | Edwards Lifesciences Technology Sarl | 14 |
| PiCCO Catheter | Pulsion Medical Systems SE | 10 |
| Co-SET+ | Edwards Lifesciences Technology Sarl | 10 |
| ICU Medical | ICU Medical, Inc | 9 |
| PiCCO catheter | Maquet Critical Care AB | 5 |
| Critikit™ | Argon Critical Care Systems Singapore PTE. Ltd. | 3 |
| PiCCO Monitoring Kit | Pulsion Medical Systems SE | 3 |
| Criticath(TM) SP5105HL TD Catheter | Argon Critical Care Systems Singapore PTE. Ltd. | 1 |
| Adler Instrument Company | Adler, Inc. | 1 |
| Co Module w/ cable & accessory | Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | 1 |
| Criticath(TM) SP5507S TD Catheter | Argon Critical Care Systems Singapore PTE. Ltd. | 1 |
| Criticath(TM) SP5507 TD Catheter | Argon Critical Care Systems Singapore PTE. Ltd. | 1 |
Showing 12 of 49. All products under Probe, Thermodilution
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.