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19 Ga. Epidural Catheterization Kit with FlexTip Plus(R) Catheter FOR EXPORT ONLY
1manufacturer
15catalogue 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 | Teleflex Medical LLC, United States |
|---|---|
| FDA product code | OGE |
| Device type | Epidural Anesthesia Kit |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5120 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2016-10-26 |
| Record revised | 2021-05-06 (version 7) |
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 | Box of 10, box of 5, case of 10, case of 5 |
| Sizes | Length 90 cm |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| IPN040190 | Length 90 cm | In distribution |
| IPN040166 | Length 90 cm | In distribution |
| IPN040166 | Length 90 cm | In distribution |
| IPN036269 | In distribution | |
| IPN042606 | In distribution | |
| IPN040190 | Length 90 cm | In distribution |
| IPN040114 | Length 90 cm | In distribution |
| IPN046839 | In distribution | |
| IPN046839 | In distribution | |
| IPN040042 | Length 90 cm | In distribution |
| IPN040192 | Length 90 cm | In distribution |
| IPN046835 | Length 90 cm | In distribution |
| IPN046838 | Length 90 cm | In distribution |
| IPN046838 | Length 90 cm | In distribution |
| IPN042606 | 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 |
| 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 |
| Medline | Medline Industries, Inc. | 4 |
| Epidural Anesthesia Kit | CHS USA Incorporated | 4 |
Showing 12 of 18. All products under Epidural Anesthesia Kit
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.