primeMIDLINE
3F (1.00mm) x 20cm Single Lumen CT Midline
1manufacturer
6catalogue numbers in this listing
2510(k) clearances naming this product code
Who Else Makes It
Registered in Zhejiang.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Terumo Medical Products (Hangzhou) Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 7 |
Record
| Listed by | PFM Medical, Inc, United States |
|---|---|
| FDA product code | PND |
| Device type | Midline Catheter |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5200 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K173114 |
| Record published | 2019-03-31 |
| Record revised | 2021-02-05 (version 4) |
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 | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Packaging | Pack of 4, pack of 5 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| PFM5SML20 | In distribution | |
| PFM4SML20 | In distribution | |
| PFM3SML20 | In distribution | |
| PFM3SML20N | In distribution | |
| PFM5DML20 | In distribution | |
| PFM4SML20N | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Midline Catheter Kit | Bard Access Systems, Inc. | 68 |
| PowerMidline | Bard Access Systems, Inc. | 57 |
| Vygon | Vygon Corp. | 36 |
| Arrow | Teleflex Medical LLC | 33 |
| Provena Midline | Bard Access Systems, Inc. | 31 |
| Peripheral Catheter Insertion Kit | Bard Access Systems, Inc. | 20 |
| Provena | Bard Access Systems, Inc. | 5 |
| BioFlo | Navilyst Medical, Inc. | 4 |
| PowerGlide ST | Bard Access Systems, Inc. | 3 |
| CT Midline Catheter | Medical Components Inc | 3 |
| 20G 8CM Stiletto Extended Dwell Catheter | Avia Vascular | 1 |
| Arch-FLO CT Midlinearch-FLO CT Midline | Medical Components Inc | 1 |
Showing 12 of 14. All products under Midline Catheter
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K192802 | 2019-10-28 |
| K173114 | 2018-03-07 |
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.