FDA.reportPublic FDA data

Sentinel Chest Seal

Primary DI
M68920001030
Brand
Sentinel Chest Seal
Company
Safeguard US Operating, LLC
Model
03
Catalog number
20-001
Device description
1 ea - dual vent chest seal with Sentinel 10x adhesive; 1 ea - wipe
Published
2018-10-26
Public version status
Update
Distribution status
Not 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
M68920001030PrimaryHIBCC0

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M6898444601190Mojo Multi Mission - Advanced1984-446-012026-05-27
M689HHCTUINK01050Chest Tube Insertion Kit05HHCTUINK012026-05-27
M689HHCTUINK0105050Chest Tube Insertion Kit Cast of 505HHCTUINK01-052026-05-27
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M68980110140SALINE LOCK KIT1480-1102025-01-11
M6898143003010Maritime Boat Box - Advanced0181-430-032025-07-11
M689HHCTUINK01040Chest Tube Insertion Kit04HHCTUINK012025-12-19
M689HHCTUINK0105040Chest Tube Insertion Kit Cast of 504HHCTUINK01-052025-12-19
M6898444601180Mojo Multi Mission - Advanced1884-446-012025-04-10
M68988143020Micro Trauma Kit - Intermediate0288-1432019-10-29
M6898130301130MARCH IFAK RESUPPLY1381-303-012026-05-05
M68980100150INTRAVENOUS INFUSION STARTER SET 1580-1002026-05-04
M6898010020040INTRAVENOUS INFUSION STARTER SET Case of 200480-100-202026-05-04
M68980801D160Fresh Whole Blood Donor Transfusion Set1680-801-D2026-05-04
M68980801R120Fresh Whole Blood Recipient Set1280-801-R2026-05-04
M6898130301120MARCH IFAK RESUPPLY1281-303-012025-08-18
M68980801D150Fresh Whole Blood Donor Transfusion Set1580-801-D2025-03-04
M68980801R110Fresh Whole Blood Recipient Set1180-801-R2025-03-04
M68980100140INTRAVENOUS INFUSION STARTER SET 1480-1002024-12-27
M6898010020030INTRAVENOUS INFUSION STARTER SET Case of 200380-100-202024-12-27

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