FDA.reportPublic FDA data

Sentinel Chest Trauma Kit

Primary DI
M68920510070
Brand
Sentinel Chest Trauma Kit
Company
Safeguard US Operating, LLC
Model
07
Catalog number
20-510
Device description
"SENTINEL CHEST TRAUMA KIT2 ea - Sentinel Dual vent Chest seals with Sentinel 10x extreme strength adhesive1 ea - Dart sterile, 14 gauge x 3.25"", needle / catheter for chest decompression1 ea - Dart Target 1 ea - wipe"
Published
2024-10-30
Public version status
Update
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
GAANeedle, Aspiration And Injection, Disposable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GAANeedle, Aspiration And Injection, DisposableGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M68920510070PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Pleural catheterA tube designed to be inserted through an intercostal space and into the pleural cavity to establish a channel for the removal of fluid (pleural effusion, blood, chyle), air (pneumothorax), or pus (empyema) to permit full expansion of the lungs typically after surgery or chest trauma. It is typically used with a pleural drainage system that uses a low negative pressure through the drain lumen. Often referred to as a chest tube, it is typically made of silicone and is available in various designs, shapes, and sizes; it may include disposable devices dedicated to catheter introduction, however it does not include fluid collection bags/containers. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

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

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Primary DI, Brand, Model table
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M68980801R120Fresh Whole Blood Recipient Set1280-801-R2026-05-04
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M689801101006080-110-10 Saline Lock Kit Case of 100680-110-102026-05-29
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M6898143003020Maritime Boat Box - Advanced0281-430-032026-05-28
M6898444601190Mojo Multi Mission - Advanced1984-446-012026-05-27
M689HHCTUINK01050Chest Tube Insertion Kit05HHCTUINK012026-05-27
M689HHCTUINK0105050Chest Tube Insertion Kit Cast of 505HHCTUINK01-052026-05-27
M689801101005080-110-10 Saline Lock Kit Case of 100580-110-102025-04-16
M68980110140SALINE LOCK KIT1480-1102025-01-11
M6898143003010Maritime Boat Box - Advanced0181-430-032025-07-11
M689HHCTUINK01040Chest Tube Insertion Kit04HHCTUINK012025-12-19

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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08800176592536WHITEROSE MICRO CANNULAUC MedicalGAA2025-09-08
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08800176592598WHITEROSE MICRO CANNULAUC MedicalGAA2025-09-08