Identity
- Trade Name
- E-Cath® NRFit Tsui® FDA UDI
- Generic Name
- Peripheral anaesthesia catheter set, non-medicated FDA UDI
- Device Name
- E-Cath® NRFit Tsui® SonoPlex® II Facet S NRFit 21G x 101mm indwelling catheter 18G x 83mm FDA UDI
- Model / Reference
- 241265-40E FDA UDI
- Description
- E-Cath® NRFit Tsui® SonoPlex® II Facet S NRFit 21G x 101mm indwelling catheter 18G x 83mm FDA UDI
Identifiers
- Catalog Number
- 241265-40E FDA UDI
- Primary DI / UDI-DI
- 04048223127988 FDA UDI
- 510(k) Number
- K152952 FDA UDI
- FDA Product Code
- BSO FDA UDI
- GMDN Term
- Peripheral anaesthesia catheter set, non-medicated FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5120 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Peripheral anaesthesia catheter set, non-medicated
E-Cath® NRFit Tsui® by Pajunk GmbH Medizintechnologie — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K152952 also covers:
- E-Cath® II Plus Tsui® — Pajunk GmbH Medizintechnologie
- E-Cath® II Plus Tsui® NRFit — Pajunk GmbH Medizintechnologie
- E-Cath® II Tsui® — Pajunk GmbH Medizintechnologie
- E-Cath® II Tsui® — Pajunk GmbH Medizintechnologie
- E-Cath® II Tsui® — Pajunk GmbH Medizintechnologie
- E-Cath® II Tsui® — Pajunk GmbH Medizintechnologie
- E-Cath® II Tsui® — Pajunk GmbH Medizintechnologie
- E-Cath® II Tsui® — Pajunk GmbH Medizintechnologie
- E-Cath® II Tsui® NRFit — Pajunk GmbH Medizintechnologie
- E-Cath® PLUS Tsui® — Pajunk GmbH Medizintechnologie
- E-Cath® Plus Tsui® — Pajunk GmbH Medizintechnologie
- E-Cath® Plus Tsui® — Pajunk GmbH Medizintechnologie
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Pajunk GmbH Medizintechnologie
Sources (1)
- FDA UDI 487a57bf-a97b-4e3f-9571-48269cc56868 37 fields · synced May 30, 2026