Sentinel Chest Seal

Basic Information

• Brand Name: Sentinel Chest Seal
• Primary DI: M68920001070
• Version / Model: 07
• Catalog Number: 20-001
• Company Name: Safeguard US Operating, LLC
• Labeler DUNS: 118492643
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-10-30
• Public Version: 1
• Public Version Date: 2024-11-07
• Public Version Status: New
• Public Device Record Key: bf7403e8-7182-464f-9352-23224a172cb3

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

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NAD	Dressing, Wound, Occlusive	General, Plastic Surgery	878.4020	1

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	M68920001070	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]