Russell Chest Seal (US Version) PDF0680

GUDID 05060483570365

The Russell Chest Seal® is a hydrogel-based dressing with an integral low-profile, four apertures, valve. The base material of the chest seal is a hydrogel matrix, which comprises a water-containing gel, mounted onto a non-woven fabric with silicon coated release liners. The Russell Chest Seal® is used to cover penetrating chest wounds, and the valve mechanism allows air to escape from the pleural cavity without being drawn back in. This aims to minimise lunge collapse associated with this injury and to facilitate lung re-inflation. The device will remain adhered over many hours and is comfortable for the patient in prolonged use (up to 24 hours).

SAFEGUARD MEDICAL TECHNOLOGIES LIMITED

Pneumothorax dressing

• Primary Device ID: 05060483570365
• NIH Device Record Key: fa86f4a7-1f79-4614-b6df-756023508736
• Commercial Distribution Discontinuation: 2026-05-04
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Russell Chest Seal (US Version)
• Version Model Number: PDF0680
• Catalog Number: PDF0680
• 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	05060483570365 [Primary]

FDA Product Code

• NAD: Dressing, Wound, Occlusive

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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