Medline
19G EPI Cath,nylon,tuohy Borst Connector
1manufacturer
4catalogue numbers in this listing
Who Else Makes It
Registered in Zhejiang. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Runqiang Medical Instruments Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 9 |
Record
| Listed by | Medline Industries, Inc., United States |
|---|---|
| FDA product code | OGE |
| Device type | Epidural Anesthesia Kit |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5120 |
| Premarket notification | Exempt |
| Record published | 2021-01-26 |
| Record revised | 2022-06-17 (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 | Case of 25, pack of 15, pack of 20 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| EPICATH19 | In distribution | |
| PHS791853002 | In distribution | |
| P533085 | In distribution | |
| EPICATH20 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Cardinal Health | Cardinal Health 200, LLC | 1,319 |
| Medline Industries, Inc. | Medline Industries, Inc. | 504 |
| Design Options® | B. Braun Medical Inc. | 361 |
| Perifix® | B. Braun Medical Inc. | 118 |
| Aligned Medical Solutions | Aligned Medical Solutions | 77 |
| Arrow | Teleflex Medical LLC | 15 |
| Epidural Anesthesia Kit Clint Pharmaceuticals | CHS USA Incorporated | 11 |
| Epidural Anesthesia Kit | Pajunk Medical Systems, LP | 11 |
| Epidural Anesthesia Kit | Custom Interventional Pain Management | 10 |
| ACS | American Contract Systems, Inc. | 8 |
| Stradis Healthcare | Stradis Healthcare | 5 |
| Epidural Anesthesia Kit | CHS USA Incorporated | 4 |
Showing 12 of 18. All products under Epidural Anesthesia Kit
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 |
|---|---|---|---|---|---|---|
| Medline Industries, LP – Northfield | UDI-DI | 2024-10-16 | Class II | Under Investigation by firm | The connectors may not allow catheters to be inserted as intended if the connector is not in the fully open position. | 5975 units |
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.