Wound Seal Duo

Basic Information

• Brand Name: Wound Seal Duo
• Primary DI: 00857048006163
• Version / Model: 1
• Catalog Number: HHWSD01
• Company Name: H&H MEDICAL CORPORATION
• Labeler DUNS: 072656713
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-12-31
• Public Version: 1
• Public Version Date: 2021-01-08
• Public Version Status: New
• Public Device Record Key: 283acbea-0acb-437b-a730-6c6278a817f0

Device Description

Wound Seal Duo, a pack of two fully occlusive hydrogel dressings for sealing multiple open chest wounds and reducing the risk of tension pneumothorax

Device Characteristics

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

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NAE	Dressing, Wound, Hydrogel Without Drug And/Or Biologic	General, Plastic Surgery	878.4022	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	00857048006163	GS1

Customer Contacts

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