ICU Medical
Thermoset™ Room Temperature Closed-Loop Injectable Delivery System with In-Line Temperature Probe
3manufacturers in China registered for this device type
9catalogue numbers in this listing
3recalls on this code
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 | ICU Medical, Inc, United States |
|---|---|
| FDA product code | KRB |
| Device type | Probe, Thermodilution |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1915 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K884318 |
| Record published | 2021-08-26 |
| Record revised | 2023-12-04 (version 2) |
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 | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Packaging | Case of 5, case of 10, case of 6, case of 20 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 41422-43 | In distribution | |
| 41227-02 | In distribution | |
| 41422-77 | In distribution | |
| 46050-38 | In distribution | |
| 41420-01 | In distribution | |
| 41424-03 | In distribution | |
| 41422-27 | In distribution | |
| 41422-01 | In distribution | |
| 41422-42 | 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 |
| 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
Recalls Naming This Product
8 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| ICU Medical, Inc | 510(k) number | 2020-01-02 | Class II | Process control | Inability for the guidewire to pass through the needles included with the catheter kits. | 260 units | 2022-09-14 |
| ICU Medical, Inc | 510(k) number | 2020-01-02 | Class II | Process control | Inability for the guidewire to pass through the needles included with the catheter kits. | 10 | 2022-09-14 |
| ICU Medical, Inc | 510(k) number | 2020-01-02 | Class II | Process control | Inability for the guidewire to pass through the needles included with the catheter kits. | 60 | 2022-09-14 |
| ICU Medical, Inc | 510(k) number | 2020-01-02 | Class II | Process control | Inability for the guidewire to pass through the needles included with the catheter kits. | 10 | 2022-09-14 |
| ICU Medical, Inc | 510(k) number | 2020-01-02 | Class II | Process control | Inability for the guidewire to pass through the needles included with the catheter kits. | 235 | 2022-09-14 |
| ICU Medical, Inc | 510(k) number | 2018-10-05 | Class II | Equipment maintenance | Potential for leakage due to defect in the thermoset check valve component. | 27,250 units total | 2021-03-25 |
| ICU Medical, Inc | 510(k) number | 2018-10-05 | Class II | Equipment maintenance | Potential for leakage due to defect in the thermoset check valve component. | 1,760 units | 2021-03-25 |
| ICU Medical, Inc | 510(k) number | 2018-10-05 | Class II | Equipment maintenance | Potential for leakage due to defect in the thermoset check valve component. | 25,640 units | 2021-03-25 |
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.