Provena
5 catalogue numbers from CK000980A, listed by Bard Access Systems, Inc., United States, under Midline Catheter. 1 manufacturer in China is registered for this product code.
1manufacturer
5catalogue numbers in this listing
3recalls on this 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 | Bard Access Systems, Inc., United States |
|---|---|
| FDA product code | PND |
| Device type | Midline Catheter |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5200 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2025-08-20 |
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 |
| Storage | Storage environment temperature 20 to 25 °C |
| Packaging | Case of 3 |
| Sizes | Catheter gauge 3 to 4 Fr; length 20 cm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| CK000980A | Catheter Gauge 4 Fr | In distribution |
| CK000715B | Catheter Gauge 3 Fr | In distribution |
| CK001092A | Length 20 cm | In distribution |
| CK000979A | Catheter Gauge 3 Fr | In distribution |
| CK000990B | Catheter Gauge 3 Fr | 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 |
| primeMIDLINE | PFM Medical, Inc | 6 |
| 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
Recalls Naming This Product
1 recall names this product by its own identifier, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Bard Access Systems, Inc. | UDI-DI | 2026-05-21 | Class II | Nonconforming Material/Component | Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier. | 2,844 |
Recalls
2 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|
| 2026-05-21 | Class II | Nonconforming Material/Component | Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier. | 24,348 |
| 2026-05-21 | Class II | Nonconforming Material/Component | Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier. | 16,887 |
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.