Umbili-Cath
A Single-Lumen Polyurethane Umbilical Catheter, 3.5 French
1manufacturer
13catalogue numbers in this listing
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 | Utah Medical Products, Inc., United States |
|---|---|
| FDA product code | FOS |
| Device type | Catheter, Umbilical Artery |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5200 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer |
| 510(k) | K940871 |
| Record published | 2016-09-23 |
| Record revised | 2026-03-19 (version 5) |
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 | Box of 10 |
| Sizes | Catheter gauge 2.8 to 8 Fr; length 34 to 37 cm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Single-Lumen Polyurethane | Catheter Gauge 3.5 Fr | In distribution |
| Dual-Lumen Polyurethane | Length 37 cm | In distribution |
| Single-Lumen Silicone | Length 34 cm | In distribution |
| Single-Lumen Polyurethane | Length 34 cm | In distribution |
| Dual-Lumen Silicone | Length 34 cm | In distribution |
| Triple-Lumen Polyurethane | Length 37 cm | In distribution |
| Dual-Lumen Polyurethane | Length 37 cm | In distribution |
| Dual-Lumen Silicone | Length 34 cm | In distribution |
| Single-Lumen Polyurethane | Length 34 cm | In distribution |
| Single-Lumen Polyurethane | Length 34 cm | In distribution |
| Dual-Lumen Polyurethane | Length 37 cm | In distribution |
| Single-Lumen Silicone | Length 34 cm | In distribution |
| Single-Lumen Silicone | Length 34 cm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Vygon | Vygon Corp. | 28 |
| Argyle | Cardinal Health | 20 |
| Argyle | Cardinal Health 200, LLC | 18 |
| Catheter, Umbilical Artery | Footprint Medical Inc. | 11 |
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.