Clamping Adapter NRFit -Yellow-
Clamping Adapter NRFit connects the open proximal end of a 20-gauge epidural or peripheral anesthesia catheter to compatible anesthetic delivery devices. It provides a common access point…
Clamping Adapter NRFit connects the open proximal end of a 20-gauge epidural or peripheral anesthesia catheter to compatible anesthetic delivery devices. It provides a common access point for continuous administration of anesthetic agents.
The NRFit version uses the ISO 80369-6 connector interface. Its role is catheter connection within an anesthesia delivery pathway, distinct from the separately offered Luer-interface adapter.
Listed Item
Clamping Adapter NRFit -yellow- sterile
Supply Configuration
The adapter is disposable and supplied sterile to end users following ethylene oxide sterilization. Nonsterile versions are supplied to repackagers or device manufacturers for sterilization before use. The listed yellow NRFit presentation is the sterile clinical configuration.
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 | Pajunk Gmbh Medizintechnologie, Germany |
|---|---|
| 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, Private-label distributor, Complaint-file establishment, Manufacturer |
| 510(k) | K172777 |
| Record published | 2018-05-22 |
| Record revised | 2025-03-17 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Storage environment humidity 20 to 65 % RH; Storage environment temperature 10 to 30 °C |
| Packaging | Pack of 10 |
| Distribution end date | 2025-03-15 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 001163-37V | In distribution | ||
| 001163-37V | 10 | Withdrawn |
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 |
|---|---|
| K172777 | 2018-05-03 |
| K152952 | 2016-07-13 |
| K080675 | 2008-06-20 |
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.