Criticath(TM) SP5537H Pacing Catheter
Heparin coated Catheter 7.5 FR, 5 Lumen with length 110 cm
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 | Argon Critical Care Systems Singapore PTE. Ltd. |
|---|---|
| FDA product code | KRB |
| Device type | Probe, Thermodilution |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1915 |
| Record published | 2016-09-22 |
| Record revised | 2023-12-04 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date |
| Packaging | Tyvek tray of 30 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 680071 | Catheter 7.5 FR, 5 Lumen with length 110 cm | 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.