Russel Pneumofix-8 (US) PDF119

GUDID 05060483570402

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.

SAFEGUARD MEDICAL TECHNOLOGIES LIMITED

Spring-loaded pneumoperitoneum needle, single-use

• Primary Device ID: 05060483570402
• NIH Device Record Key: 03ab8613-8e56-4968-b69d-aab63a2e6e99
• Commercial Distribution Discontinuation: 2028-05-04
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Russel Pneumofix-8 (US)
• Version Model Number: PDF119
• Catalog Number: PDF119
• Company DUNS: 219545612
• Company Name: SAFEGUARD MEDICAL TECHNOLOGIES LIMITED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	05060483570402 [Primary]

FDA Product Code

• GCB: Needle, Catheter

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Device Record Status: Published
• Public Version Number: 0
• Device Publish Date: 2023-05-04

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