AccessGUDID - DEVICE: Russell Chest Seal (US Version) (05060483570365)

GUDID

Device Identifier (DI) Information

Brand Name: Russell Chest Seal (US Version)
Version or Model: PDF0680
Commercial Distribution Status: In Commercial Distribution
Catalog Number: PDF0680
Company Name: SAFEGUARD MEDICAL TECHNOLOGIES LIMITED

Primary DI Number: 05060483570365
Issuing Agency: GS1
Commercial Distribution End Date: May 04, 2026
Device Count: 1
Labeler D-U-N-S® Number*: 219545612 *Terms of Use

Device Description: 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).

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?
46424	Pneumothorax dressing	A sterile covering applied to a chest wound that has penetrated the pleura (serous membrane covering the lungs and lining the pleural cavity) in order to temporarily treat and prevent pneumothorax (collapsed lung). The device may be self-adhesive and have a one-way valve that enables internal pressure release while preventing air entry. It is typically used by first responders [emergency medical services (EMS)] in the management of penetrating chest trauma (e.g., bullet or stab wounds). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NAD	Dressing, Wound, Occlusive

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: fa86f4a7-1f79-4614-b6df-756023508736
Public Version Date: May 12, 2023
Public Version Number: 1
DI Record Publish Date: May 04, 2023