ICU Medical
Central Venous Catheter, Heparin Coated, 3 Lumen, 16/18/18 G, 30 cm, PMAP, Expanded Kit
1manufacturer
65catalogue numbers in this listing
1510(k) clearance
7recalls on this code
Who Else Makes It
Registered in Guangdong. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amphenol Medical Technologies (Dongguan) Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 77 |
Record
| Listed by | ICU Medical, Inc, United States |
|---|---|
| FDA product code | DQE |
| Device type | Catheter, Oximeter, Fiber-Optic |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1230 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K091268 |
| Record published | 2021-08-29 |
| 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 6, case of 10, box of 4, case, box of 4, box of 5 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 50407 | In distribution | |
| 41413-15 | In distribution | |
| 41239-06 | In distribution | |
| 41401-25 | In distribution | |
| 52515 | In distribution | |
| 41232-01 | In distribution | |
| 41216-02 | In distribution | |
| 41414-23 | In distribution | |
| 011-41400-13 | In distribution | |
| 41233-02 | In distribution | |
| 886-50324-07 | In distribution | |
| 50458-01 | In distribution | |
| 52515 | In distribution | |
| 50465-01 | In distribution | |
| 50327 | In distribution | |
| 41411-23 | In distribution | |
| 41240-06 | In distribution | |
| 41248-05 | In distribution | |
| 41251-05 | In distribution | |
| 52511 | In distribution | |
| 52510 | In distribution | |
| 41231-05 | In distribution | |
| 52516 | In distribution | |
| 50456-01 | In distribution | |
| 41251-06 | In distribution | |
| 41223-01 | In distribution | |
| 41237-05 | In distribution | |
| 41411-25 | In distribution | |
| 41401-23 | In distribution | |
| 41400-15 | In distribution | |
| 41227-01 | In distribution | |
| 41239-05 | In distribution | |
| 50337 | In distribution | |
| 41229-02 | In distribution | |
| 41406-23 | In distribution | |
| 011-41232-01 | In distribution | |
| 41231-06 | In distribution | |
| 41233-01 | In distribution | |
| 50324 | In distribution | |
| 41223-02 | In distribution | |
| 41407-23 | In distribution | |
| 52509 | In distribution | |
| 50328 | In distribution | |
| PCX45D | In distribution | |
| 41217-01 | In distribution | |
| 41240-05 | In distribution | |
| 50404-01 | In distribution | |
| 41248-06 | In distribution | |
| 41217-02 | In distribution | |
| 50328 | In distribution | |
| 011-41229-01 | In distribution | |
| 886-52510-14 | In distribution | |
| 50327 | In distribution | |
| 41232-02 | In distribution | |
| 52510 | In distribution | |
| 50467-01 | In distribution | |
| 011-41434-01 | In distribution | |
| 41237-06 | In distribution | |
| 50405-01 | In distribution | |
| 50472 | In distribution | |
| 50337 | In distribution | |
| 41229-01 | In distribution | |
| 50355 | In distribution | |
| 50354 | In distribution | |
| 41216-01 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Vital Signs™ | AirLife Finland Oy | 12 |
| Swan-Ganz | Edwards Lifesciences Technology Sarl | 7 |
| Edwards Oximetry Central Venous Catheter | Edwards Lifesciences Technology Sarl | 6 |
| Vital Signs | Carefusion Finland 320 Oy | 6 |
| HemoSphere | Edwards Lifesciences Technology Sarl | 5 |
| Swan-Ganz True Size | Edwards Lifesciences Technology Sarl | 3 |
| HemoSphere Alta | Edwards Lifesciences Technology Sarl | 3 |
| Flotrac | Edwards Lifesciences Technology Sarl | 3 |
| Vigileo | Edwards Lifesciences Technology Sarl | 2 |
| ForeSight IQ | Edwards Lifesciences Technology Sarl | 1 |
| Pediasat | Edwards Lifesciences Technology Sarl | 1 |
| Presep | Edwards Lifesciences Technology Sarl | 1 |
Showing 12 of 18. All products under Catheter, Oximeter, Fiber-Optic
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K140129 | 2014-07-02 |
Recalls Naming This Product
5 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 |
Recalls
2 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2020-01-02 | Class II | Process control | Inability for the guidewire to pass through the needles included with the catheter kits. | 20 | 2022-09-14 |
| 2020-01-02 | Class II | Process control | Inability for the guidewire to pass through the needles included with the catheter kits. | 15 | 2022-09-14 |
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.