Epimed International, Inc.
Tun-L--XL™/24 19g X 24" w/ R.K.™ 16 TW X 3.5" w/ plastic LOR
1manufacturer
6catalogue numbers in this listing
4510(k) clearances naming this product code
5recalls on this code
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 | Epimed International, Inc., United States |
|---|---|
| FDA product code | BSO |
| Device type | Catheter, Conduction, Anesthetic |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5120 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K023140 |
| Record published | 2017-10-24 |
| Record revised | 2023-03-03 (version 6) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Sterilisation | Ethylene Oxide |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Handling environment temperature 50 to 90 °F |
| Packaging | Case of 5, case of 10 |
| Sizes | Length 3.5 to 24 in; catheter gauge 2.4 to 3.2 Fr; needle gauge 16 to 18 G |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 181-2112 | Needle Gauge 18 G | In distribution |
| 181-2542 | Length 3.5 in | In distribution |
| 161-2114 | 2.4Ch | In distribution |
| 161-2124 | 24in | In distribution |
| 181-2340 | Catheter Gauge 3.2 Fr | In distribution |
| 181-2393 | Length 3.5 in | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Arrow | Teleflex Medical LLC | 366 |
| Epimed | Epimed International, Inc. | 56 |
| Avanos | Avanos Medical, Inc. | 48 |
| E-Cath Tsui | Pajunk Gmbh Medizintechnologie | 47 |
| Halyard | Avanos Medical, Inc. | 34 |
| Infiltralong | Pajunk Gmbh Medizintechnologie | 25 |
| E-Cath acc. Tsui | Pajunk Gmbh Medizintechnologie | 21 |
| E-Cath Plus acc. Tsui | Pajunk Gmbh Medizintechnologie | 17 |
| Epinaut | Imedicom Co., Ltd. | 16 |
| E-Cath® Plus Tsui® | Pajunk Gmbh Medizintechnologie | 10 |
| E-Cath® II Tsui® | Pajunk Gmbh Medizintechnologie | 9 |
| Spinaut-E | Imedicom Co., Ltd. | 9 |
Showing 12 of 65. All products under Catheter, Conduction, Anesthetic
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K200624 | 2020-04-27 |
| K133316 | 2014-05-28 |
| K023140 | 2003-08-15 |
| K981329 | 1998-08-26 |
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 |
|---|---|---|---|---|---|---|---|
| Epimed International, Inc. | 510(k) number | 2021-02-01 | Class II | Process control | Outer coating of the catheter may deteriorate and result in the coating to crack and/or potentially flake off | 5835 units | 2022-10-17 |
| Epimed International, Inc. | 510(k) number | 2019-06-18 | Class II | Labeling mix-ups | Mislabeled – The product’s labeling contains an incorrect size for the catheter included in the kit. The kit contains a 21 gauge catheter, however the labeling states a 12 gauge catheter is included. | 200 kits | |
| Epimed International, Inc. | 510(k) number | 2019-06-18 | Class II | Labeling mix-ups | Mislabeled – The product’s labeling contains an incorrect size for the catheter included in the kit. The kit contains a 21 gauge catheter, however the labeling states a 12 gauge catheter is included. | 98 kits |
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 |
|---|---|---|---|---|
| 2017-12-28 | Class II | Process control | Potential for stylet to protrude from the distal end of the catheter | 140 units |
| 2017-12-28 | Class II | Process control | Potential for stylet to protrude from the distal end of the catheter | 132 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.