AccessGUDID - DEVICE: Russel Pneumofix-8 (US) (05060483570402)

GUDID

Device Identifier (DI) Information

Brand Name: Russel Pneumofix-8 (US)
Version or Model: PDF119
Commercial Distribution Status: In Commercial Distribution
Catalog Number: PDF119
Company Name: SAFEGUARD MEDICAL TECHNOLOGIES LIMITED

Primary DI Number: 05060483570402
Issuing Agency: GS1
Commercial Distribution End Date: May 04, 2028
Device Count: 1
Labeler D-U-N-S® Number*: 219545612 *Terms of Use

Device 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.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
12750	Spring-loaded pneumoperitoneum needle, single-use	A slender, sharply-pointed metal tube designed to introduce or remove gas from the peritoneal cavity as a therapeutic or surgical/radiological procedural method. It is often inserted into the peritoneal cavity for the purpose of insufflation [e.g., with carbon dioxide (CO2)] to establish pneumoperitoneum prior to abdominal endoscopy. It is equipped with a spring-loaded, round-tipped obturator that extends from the tube when the device does not encounter resistance (i.e., when the cavity has been reached) to prevent damage from the sharp point. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GCB	Needle, Catheter

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 03ab8613-8e56-4968-b69d-aab63a2e6e99
Public Version Date: May 12, 2023
Public Version Number: 1
DI Record Publish Date: May 04, 2023