Argyle
PVC Umbilical Vessel Catheter Single Lumen 3.5 Fr/Ch (1.2 mm) x 9-8/10in (25 cm)
1manufacturer
20catalogue 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 | Cardinal Health, United States |
|---|---|
| FDA product code | FOS |
| Device type | Catheter, Umbilical Artery |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5200 |
| Establishment | Contract manufacturer, Reprocessor, Contract steriliser, Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| Record published | 2016-10-14 |
| Record revised | 2025-12-31 (version 13) |
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 | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Keep dry;AVOID DIRECT SUNLIGHT |
| Packaging | Case of 5, pack_or_inner_pack of 10, pack_or_inner_pack of 5, case of 10 |
| Sizes | Catheter gauge 2.5 to 8 Fr; length 9.8 to 16 in; total volume 0.08 to 0.33 ml |
| Distribution end date | 2025-12-31 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 8888160366 | Length 15 in | In distribution |
| 8888160226 | Catheter Gauge 5 Fr | In distribution |
| 8888160234 | Length 16 in | In distribution |
| 8888160374 | Length 9.80 in | In distribution |
| 8888160457 | Catheter Gauge 5 Fr | In distribution |
| 8888160440 | Catheter Gauge 3.5 Fr | In distribution |
| 8888160218 | Catheter Gauge 3.5 Fr | In distribution |
| 8888160325 | Length 9.80 in | Withdrawn |
| 8888160333 | Total Volume.15 ml | Withdrawn |
| 160409 | Withdrawn | |
| 43201 | Withdrawn | |
| 8888160838 | Catheter Gauge 3.5 Fr | Withdrawn |
| 8888160853 | Catheter Gauge 5 Fr | Withdrawn |
| 8888160648 | Catheter Gauge 5 Fr | Withdrawn |
| 8888160358 | Catheter Gauge 3.5 Fr | Withdrawn |
| 8888160531 | Lumen Diameter,20/23,Gauge;Total Volume,0.21 and 0.16,Milliliter; | Withdrawn |
| 8888160663 | Catheter Gauge 8 Fr | Withdrawn |
| 8888160341 | Total Volume.33 ml | Withdrawn |
| 8888160408 | Withdrawn | |
| 8888160556 | Catheter Gauge 5 Fr | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Vygon | Vygon Corp. | 28 |
| Argyle | Cardinal Health 200, LLC | 18 |
| Umbili-Cath | Utah Medical Products, Inc. | 13 |
| 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.