FDA.reportPublic FDA data

Russell Chest Seal (US Version)

Primary DI
05060483570365
Brand
Russell Chest Seal (US Version)
Company
SAFEGUARD MEDICAL TECHNOLOGIES LIMITED
Model
PDF0680
Catalog number
PDF0680
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).
Published
2023-05-04
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
NADDressing, Wound, Occlusive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NADDressing, Wound, OcclusiveGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060483570365PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060483570365050604835703655060483570365

GMDN Terms#

Term, Definition table
TermDefinition
Pneumothorax dressingA 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
219545612
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
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15060483570041Prometheus Pelvic Splint - Case of 40pcsPRO400PRO4002024-10-27
05060483571638TMT (Tactical Mechanical Tourniquet) PDF186PDF1862024-10-02
05060483571669TMT (Tactical Mechanical Tourniquet) - USPDF185PDF1852024-10-02
05060483571867TMT (Tactical Mechanical Tourniquet) PDF187PDF1872024-10-02
05060483571508SWAT-T TourniquetPDF165PDF1652024-09-03
05060483571515SWAT-T TourniquetPDF166PDF1662024-09-03
05060483570099Prometheus Omni Splint Rolled PDF105PML1052023-05-04
05060483570105Prometheus Omni Splint Flat PML115PML1152023-05-04
05060483570112Russell PneumoFix (US) PDF112PDF1122023-05-04
05060483570150Prometheus Steady Head PDF104PDF1042023-05-04
05060483570389Prometheus FullStop Tourniquet - BlackPDF180PDF1802023-05-04
05060483570396Prometheus FullStop Tourniquet - Hi VisibilityPDF181PDF1812023-05-04
05060483570402Russel Pneumofix-8 (US) PDF119PDF1192023-05-04
05060483570051Prometheus Traction Splint PDF101PDF1012023-05-01

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