Identity
- Trade Name
- Russel Pneumofix-8 (US) FDA UDI
- Generic Name
- Spring-loaded pneumoperitoneum needle, single-use FDA UDI
- Device Name
- The Russell PneumoFix®-8 is a sterile decompression needle composed of a veress-tipped needle inserted through an 8cm catheter, with a low-pressure release valve. The veress tip and indicator device assist with the safe insertion with a minimal risk of injuring the underlying lung, whilst the low-pressure release valve permits the release of tension pneumothorax with minimal potential of subsequent air re-entry. The Russell PneumoFix®-8 is composed of a stainless steel veress-tipped needle with a Tecoflex Polyurethane catheter. The catheter contains barium sulphate (20%) which enables the catheter to be visible during X-ray. FDA UDI
- Model / Reference
- PDF119 FDA UDI
- Description
- The Russell PneumoFix®-8 is a sterile decompression needle composed of a veress-tipped needle inserted through an 8cm catheter, with a low-pressure release valve. The veress tip and indicator device assist with the safe insertion with a minimal risk of injuring the underlying lung, whilst the low-pressure release valve permits the release of tension pneumothorax with minimal potential of subsequent air re-entry. The Russell PneumoFix®-8 is composed of a stainless steel veress-tipped needle with a Tecoflex Polyurethane catheter. The catheter contains barium sulphate (20%) which enables the catheter to be visible during X-ray. FDA UDI
Identifiers
- Catalog Number
- PDF119 FDA UDI
- Primary DI / UDI-DI
- 05060483570402 FDA UDI
- FDA Product Code
- GCB FDA UDI
- GMDN Term
- Spring-loaded pneumoperitoneum needle, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4200 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
Yes
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Spring-loaded pneumoperitoneum needle, single-use
Russel Pneumofix-8 (US) by Safeguard Medical Technologies Limited — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 I | Pending data |
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Manufacturer
- Manufacturer
- Safeguard Medical Technologies Limited
Sources (1)
- FDA UDI 03ab8613-8e56-4968-b69d-aab63a2e6e99 35 fields · synced May 31, 2026