Clamping Adapter NRFit -White-
The Clamping Adapter NRFit connects an anesthesia delivery device to the open end of a catheter. It provides a common access point for continuous administration of anesthetic agents through…
The Clamping Adapter NRFit connects an anesthesia delivery device to the open end of a catheter. It provides a common access point for continuous administration of anesthetic agents through an epidural or peripheral nerve catheter. The adapter is intended for a 20 gauge anesthesia conduction catheter.
The adapter clamps around the catheter to secure the connection. Its body is polycarbonate and its clamping seal is silicone. The NRFit connector uses dimensions specified for neuraxial applications to reduce the possibility of connection to a different connector type.
Listed Item
Clamping Adapter NRFit -white- sterile
Supply and Compatibility
This configuration uses the NRFit connection specified by ISO 80369-6. The finished device is disposable and supplied sterile for the end user; it serves as a connection accessory for the catheter rather than as the catheter itself.
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 |
|---|---|---|---|
| 001163-38C | In distribution | ||
| 001163-38C | 10 | Withdrawn |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.