FDA.reportPublic FDA data

H-Vent Vented Chest Seal

Primary DI
M689HVPIK060
Brand
H-Vent Vented Chest Seal
Company
Safeguard US Operating, LLC
Model
06
Catalog number
HVPIK
Device description
H*VENT Penetrating Injury Kit is apart of the Sterile Wound Seal Family of Products to be used by emergency medical personnel in the battlefield or pre-hospital setting. Provides a fast application for sealing wounds quickly to stop external bleeding.
Published
2026-10-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
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
M689HVPIK060PrimaryHIBCC0

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.

Contacts#

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

Regulatory Flags#

DUNS number
118492643
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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