FDA.reportPublic FDA data

Sentinel Chest Seal

Primary DI
M68920001070
Brand
Sentinel Chest Seal
Company
Safeguard US Operating, LLC
Model
07
Catalog number
20-001
Device description
The Sentinel® Chest Seal is a device designed to seal an open chest wound and minimize the risk of developing tension pneumothorax.1 ea - sterile dual vent chest seal with Sentinel 10x adhesive; 1 ea - wipe
Published
2024-10-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

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
M68920001070PrimaryHIBCC0

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

Contacts#

Phone, Email table
PhoneEmail
855-428-6074fulfillment@combatmedical.com

Regulatory Flags#

DUNS number
118492643
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

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M689HHCTUINK01050Chest Tube Insertion Kit05HHCTUINK012026-05-27
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M689801101005080-110-10 Saline Lock Kit Case of 100580-110-102025-04-16
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M6898143003010Maritime Boat Box - Advanced0181-430-032025-07-11
M689HHCTUINK01040Chest Tube Insertion Kit04HHCTUINK012025-12-19

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Primary DI, Brand, Company table
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