Co-SET+
Co-SET(R) AND Syringe F/USE W/ 93-500,-510,-600,-610 5EA/CA
3manufacturers in China registered for this device type
10catalogue numbers in this listing
1510(k) clearance
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 | Edwards Lifesciences Technology Sarl, United States |
|---|---|
| FDA product code | KRB |
| Device type | Probe, Thermodilution |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1915 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer |
| 510(k) | K811399 |
| Record published | 2016-09-03 |
| Record revised | 2018-09-12 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: STORE IN A COOL, DRY PLACE. |
| Packaging | Shipper of 10, shipper of 8, shipper of 5 |
| Sizes | Length 12 to 96 in; total volume 10 ml |
| Distribution end date | 2016-11-21 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 93505 | SIZED FOR USE WITH THE EDWARDS CO-SET+ IN-LINE INJECTATE TEMPERATURE PROBE (MODEL 93522) AND ATTACHMENT TO THE CATHETER INJECTATE LUMEN STOPCOCK. | In distribution |
| 93650 | Total Volume 10 ml | In distribution |
| 93528 | Length 96 in | In distribution |
| MK2431 | Length 12 in | In distribution |
| 93610 | Total Volume 10 ml | In distribution |
| 93524 | Length 78 in | In distribution |
| 93529 | Length 42 in | In distribution |
| 93600 | Total Volume 10 ml | In distribution |
| 93522 | Length 96 in | In distribution |
| 93611 | Total Volume 10 ml | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| VolumeView | Edwards Lifesciences Technology Sarl | 14 |
| PiCCO Catheter | Pulsion Medical Systems SE | 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 |
| Criticath SP5507-13 TD Catheter | Argon Critical Care Systems Singapore PTE. Ltd. | 1 |
Showing 12 of 49. All products under Probe, Thermodilution
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K100739 | 2010-12-07 |
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.