Arrow
Pressure Injectable Arrowg+ard Blue Advance(R) One-Lumen Midline Kit
1manufacturer
33catalogue numbers in this listing
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 | Teleflex Medical LLC, 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 |
| 510(k) | K161313 |
| Record published | 2017-03-30 |
| Record revised | 2023-10-11 (version 11) |
Specifications
| MRI safety | MR Safe |
|---|---|
| Sterilisation | Ethylene Oxide |
| 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, manufacturing date |
| Storage | Storage environment temperature up to 25 °C; Special storage condition: Avoid excessive heat above 30°C (86°F). |
| Packaging | Case of 5, case of 3, case |
| Sizes | Catheter gauge 4.5 to 5.5 Fr |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| IPN037697 | In distribution | |
| IPN914812 | In distribution | |
| IPN029733 | In distribution | |
| IPN055404 | In distribution | |
| IPN037698 | Catheter Gauge 5.5 Fr | In distribution |
| IPN921996 | In distribution | |
| IPN038090 | Catheter Gauge 5.5 Fr | In distribution |
| IPN038357 | In distribution | |
| IPN928657 | In distribution | |
| IPN038186 | In distribution | |
| IPN929202 | In distribution | |
| IPN029734 | In distribution | |
| IPN921959 | In distribution | |
| IPN929203 | In distribution | |
| IPN927039 | In distribution | |
| IPN056912 | In distribution | |
| IPN037697 | In distribution | |
| IPN038187 | In distribution | |
| IPN919547 | In distribution | |
| IPN921958 | In distribution | |
| IPN928656 | In distribution | |
| IPN919546 | In distribution | |
| IPN037698 | In distribution | |
| IPN037698 | In distribution | |
| IPN037697 | Catheter Gauge 4.5 Fr | In distribution |
| IPN056294 | In distribution | |
| IPN921993 | In distribution | |
| IPN927041 | In distribution | |
| IPN038643 | In distribution | |
| IPN038089 | Catheter Gauge 4.5 Fr | In distribution |
| IPN921995 | In distribution | |
| IPN921957 | In distribution | |
| IPN921994 | 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 |
| 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 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | 510(k) number | 2026-04-21 | Class I | Nonconforming Material/Component | Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-bas | 90 | |
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | 510(k) number | 2022-09-14 | Class II | Under Investigation by firm | Mislabeling: the corrugate label, lidstock, banner card, and peel sticker accompanying the affected product incorrectly displays a double lumen 5.5 French catheter (and related priming volumes and kit contents for product code ASK-41552-JH | 18 devices | 2024-01-19 |
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | 510(k) number | 2019-04-23 | Class II | Process control | Lidstock states the incorrect expiration date for the product | 430 units | 2021-01-13 |
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.