Catheter, Umbilical Artery
4.3Fr Single Lumen Polyurethane Umbilical Catheter
1manufacturer
11catalogue numbers in this listing
3510(k) clearances naming this product code
Who Else Makes It
Registered in Guangdong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Haolang Technology (Foshan) Limited Corporation | Foshan | Guangdong | Contract manufacturer | 6 |
Record
| Listed by | Footprint Medical Inc., United States |
|---|---|
| FDA product code | FOS |
| Device type | Catheter, Umbilical Artery |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5200 |
| Establishment | Contract manufacturer, Manufacturer |
| 510(k) | K120304 |
| Record published | 2016-09-20 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Packaging | Carton of 5 |
| Sizes | Catheter gauge 2.5 to 6.5 Fr |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| P1UVC-4340 | Catheter Gauge 4.3 Fr | In distribution |
| P1UVC-540 | Catheter Gauge 5.0 Fr | In distribution |
| P1UVC-2530 | Catheter Gauge 2.5 Fr | In distribution |
| P2UVC3.5 | Catheter Gauge 3.5 Fr | In distribution |
| S2UVC-436 | Catheter Gauge 4.0 Fr | In distribution |
| S2UVC-536 | Catheter Gauge 5.0 Fr | In distribution |
| S1UVC-3540 | Catheter Gauge 3.5 Fr | In distribution |
| S1UVC-6540 | Catheter Gauge 6.5 Fr | In distribution |
| P2UVC5.0 | Catheter Gauge 5.0 Fr | In distribution |
| S1UVC-540 | Catheter Gauge 5.0 Fr | In distribution |
| P1UVC-3540 | Catheter Gauge 3.5 Fr | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Vygon | Vygon Corp. | 28 |
| Argyle | Cardinal Health | 20 |
| Argyle | Cardinal Health 200, LLC | 18 |
| Umbili-Cath | Utah Medical Products, Inc. | 13 |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K120304 | 2012-03-01 |
| K091213 | 2009-09-25 |
| K091214 | 2009-09-25 |
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.