Vygon
Umbilical catheter - 4Fr - L.20cm - PUR (double lumen - 11ml/min / 12ml/min)
1manufacturer
28catalogue 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 | Vygon Corp., United States |
|---|---|
| FDA product code | FOS |
| Device type | Catheter, Umbilical Artery |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5200 |
| Record published | 2022-04-21 |
| Record revised | 2018-10-22 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 5 to 40 °C |
| Packaging | Pack of 15, case of 15, box of 15, pack of 9, pack of 10, pack of 20 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 270.08 | In distribution | |
| 1270.04 | In distribution | |
| 1272.14 | In distribution | |
| 270.07 | In distribution | |
| 270.04 | In distribution | |
| 270.03 | In distribution | |
| 1270.03 | In distribution | |
| 1270.08 | In distribution | |
| 270.06 | In distribution | |
| 270.03 | In distribution | |
| 270.04 | In distribution | |
| 1272.14 | In distribution | |
| 1270.05 | In distribution | |
| 270.07 | In distribution | |
| 1274.17 | In distribution | |
| 1274.14 | In distribution | |
| 1270.03 | In distribution | |
| 1270.08 | In distribution | |
| 270.06 | In distribution | |
| 1270.02 | In distribution | |
| 1270.02 | In distribution | |
| 270.05 | In distribution | |
| 270.08 | In distribution | |
| 1274.14 | In distribution | |
| 1270.05 | In distribution | |
| 1270.04 | In distribution | |
| 270.05 | In distribution | |
| 1274.17 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Argyle | Cardinal Health | 20 |
| Argyle | Cardinal Health 200, LLC | 18 |
| Umbili-Cath | Utah Medical Products, Inc. | 13 |
| Catheter, Umbilical Artery | Footprint Medical Inc. | 11 |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K921352 | 1992-10-26 |
| K921374 | 1992-10-26 |
| K851005 | 1985-05-21 |
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.