Argyle
Acute Single Lumen Catheter Kit,Straight Extension,8 Fr/Ch (2.7 mm) x 19.5 cm
1manufacturer
4catalogue numbers in this listing
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 |
|---|---|---|---|---|
| Turnxon Precision Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 17 |
Record
| Listed by | Mozarc Medical US LLC, United States |
|---|---|
| FDA product code | LFJ |
| Device type | Catheter, Subclavian |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5540 |
| Establishment | Specification developer, Manufacturer |
| Record published | 2015-10-22 |
| Record revised | 2025-04-29 (version 9) |
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 |
| Packaging | Pack_or_inner_pack of 5, case of 25 |
| Sizes | Length 15 to 19.5 cm; catheter gauge 8 Fr |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 8818782001 | In distribution | |
| 8831173011 | Length 19.5 cm | In distribution |
| 8817232019 | Length 19.5 cm | In distribution |
| 8831173010 | Length 15 cm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Arrow | Teleflex Medical LLC | 45 |
| Hemo-Cath® | Medical Components Inc | 37 |
| SLX Hemo-Cath® | Medical Components Inc | 28 |
| Permcath | Mozarc Medical US LLC | 9 |
| Silicone Hemo-Cath-NO Cuff/Acutesilicone Hemo-Cath-NO Cuff/Acute | Medical Components Inc | 6 |
| Brevia Short Term Dialysis Catheter | Bard Access Systems, Inc. | 4 |
| Mahurkar | Mozarc Medical US LLC | 4 |
| Brevia Dialysis Catheter Kit | Bard Access Systems, Inc. | 4 |
| Schon | AngioDynamics, Inc. | 4 |
| Hemo-Cath® Silicone | Medical Components Inc | 3 |
| Hemo-Cath®ij | Medical Components Inc | 2 |
| Soft-Cell Dialysis Catheter Kit 12.5 F x 19 cm | Bard Access Systems, Inc. | 1 |
Showing 12 of 25. All products under Catheter, Subclavian
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.