Midline Catheter Kit
4Fr DL Provena Midline Max Barrier Kit w/GuardIVa and Probe Cover
1manufacturer
68catalogue 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 | 2019-09-19 |
| Record revised | 2024-01-08 (version 3) |
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, case of 5 |
| Sizes | Catheter gauge 3 to 5 Fr; length 20 cm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| PP4254108DGP | Catheter Gauge 4 Fr | In distribution |
| PP4154108DGP | Catheter Gauge 4 Fr | In distribution |
| PP4254108DGPX | Catheter Gauge 4 Fr | In distribution |
| P4153108D | Catheter Gauge 3 Fr | In distribution |
| S4254108DGP | Catheter Gauge 4 Fr | In distribution |
| S4153108G | Catheter Gauge 3 Fr | In distribution |
| PP4255108DGP | Length 20 cm | In distribution |
| SP4153108D | Catheter Gauge 3 Fr | In distribution |
| P4154108DG | Catheter Gauge 4 Fr | In distribution |
| S4254108D | Catheter Gauge 4 Fr | In distribution |
| S4153108B | Catheter Gauge 3 Fr | In distribution |
| PP4154108D | Length 20 cm | In distribution |
| S4254108 | Catheter Gauge 4 Fr | In distribution |
| SP4254108DG | Length 20 cm | In distribution |
| PP4153108DBPX | Catheter Gauge 3 Fr | In distribution |
| PP4255108DBPX | Catheter Gauge 5 Fr | In distribution |
| S4254108B | Catheter Gauge 4 Fr | In distribution |
| S4254108BDP | Length 20 cm | In distribution |
| S4254118 | Catheter Gauge 4 Fr | In distribution |
| PP4153108D | Catheter Gauge 3 Fr | In distribution |
| P4154108D | Length 20 cm | In distribution |
| PP4154108DBPX | Length 20 cm | In distribution |
| PP4254108D | Catheter Gauge 4 Fr | In distribution |
| PP4255108DBP | Length 20 cm | In distribution |
| S4254108DG | Catheter Gauge 4 Fr | In distribution |
| PP4255108DGPX | Catheter Gauge 5 Fr | In distribution |
| P4153108G | Length 20 cm | In distribution |
| SP4153108DB | Length 20 cm | In distribution |
| PP4154108DBP | Catheter Gauge 4 Fr | In distribution |
| P4154108G | Catheter Gauge 4 Fr | In distribution |
| S4153108D | Length 20 cm | In distribution |
| S4254108BP | Length 20 cm | In distribution |
| S4254108GP | Catheter Gauge 4 Fr | In distribution |
| SP4153108DG | Length 20 cm | In distribution |
| S4153108BDP | Length 20 cm | In distribution |
| SP4254108DB | Catheter Gauge 4 Fr | In distribution |
| PP4255108D | Catheter Gauge 5 Fr | In distribution |
| P4255108 | Catheter Gauge 5 Fr | In distribution |
| S4254108BD | Catheter Gauge 4 Fr | In distribution |
| P4154118 | Catheter Gauge 4 Fr | In distribution |
| P4153108DG | Catheter Gauge 3 Fr | In distribution |
| P4254108 | Length 20 cm | In distribution |
| PP4254108DBP | Length 20 cm | In distribution |
| P4153108 | Length 20 cm | In distribution |
| S4153108DG | Length 20 cm | In distribution |
| P4255108DG | Catheter Gauge 5 Fr | In distribution |
| S4254108G | Length 20 cm | In distribution |
| S4153108 | Catheter Gauge 3 Fr | In distribution |
| P4254108DG | Length 20 cm | In distribution |
| P4255118 | Length 20 cm | In distribution |
| PP4153108DGPX | Catheter Gauge 3 Fr | In distribution |
| SP4254108D | Catheter Gauge 4 Fr | In distribution |
| S4153108DGP | Catheter Gauge 3 Fr | In distribution |
| P4153118 | Length 20 cm | In distribution |
| P4255108G | Catheter Gauge 5 Fr | In distribution |
| P4255108D | Length 20 cm | In distribution |
| PP4254108DBPX | Length 20 cm | In distribution |
| PP4154108DGPX | Catheter Gauge 4 Fr | In distribution |
| S4153108BP | Length 20 cm | In distribution |
| P4254118 | Length 20 cm | In distribution |
| S4153118 | Length 20 cm | In distribution |
| S4153108GP | Catheter Gauge 3 Fr | In distribution |
| P4254108D | Length 20 cm | In distribution |
| S4153108BD | Catheter Gauge 3 Fr | In distribution |
| P4254108G | Catheter Gauge 4 Fr | In distribution |
| PP4153108DBP | Length 20 cm | In distribution |
| PP4153108DGP | Catheter Gauge 3 Fr | In distribution |
| P4154108 | Catheter Gauge 4 Fr | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| 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 |
| 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
Recalls Naming This Product
3 recalls name this product by its own identifiers, 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. | 16,887 |
| 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 |
| 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. | 24,348 |
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.