FDA.reportPublic FDA data

Compact Wound Seal Kit

Primary DI
M689HHCWS01040
Brand
Compact Wound Seal Kit
Company
Safeguard US Operating, LLC
Model
04
Catalog number
HHCWS01
Device description
Compact Wound Seal Kit is a hydrogel-based dressing non-vented seal used by emergency medical personnel in the Battlefield/or Pre-hospital. Intended for use on adult patients who have suffered an open wound to prevent the escape of air to retain air circulation.
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
NAEDressing, Wound, Hydrogel Without Drug And/Or Biologic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NAEDressing, Wound, Hydrogel Without Drug And/Or BiologicGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M689HHCWS01040PrimaryHIBCC0

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
true
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
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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M68931200070CrOC0731-2002026-10-08
M6898723101011Bleeding Control Kit0187-231-012022-09-15
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M68981129060Mojo Patrol IFAK II0681-1292026-08-26
M689SDREDC1OTC050SDR-EDC1-OTC05SDR-EDC1-OTC2026-08-26
M689SDRTBBOTC060SDR Tactical Battle Belt IFAK-OTC06SDR-TBB-OTC2026-08-26
M68981139010LEO Patrol Kit0181-1392026-08-25
M68981301030MARCH IFAK Refill0381-3012026-08-25
M6898130330010MARCH IFAK RESUPPLY Cs of 300181-303-302026-08-25
M68981605020K9 Trauma Kit0281-6052026-08-25
M68987155030TX Bleeding Control Kit - Advanced0387-1552026-08-25
M68987232010Stop the Bleed Kit (NJSP)0187-2322026-08-25
M689SDREDC1OTC010SDR-EDC1OTC01SDR-EDC1OTC2026-08-25
M689SDRTBBOTC020SDR Tactical Battle Belt IFAK-OTC02SDR-TBBOTC2026-08-25
M689HHSCK01EA020Simplified Cricothyrotomy Kit02HHSCK01-EA2022-08-10
M68985201020Mojo Vehicle Rescue Bag - Basic0285-2012026-01-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
M689TOCSEA030Curaplex TOCSSafeguard US Operating, LLCNAE2026-10-13
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00743537001231BurnFreeWATER-JEL TECHNOLOGIES, L.L.C.NAE2026-10-05
00841277111248Novera BalanceHarps USA, Inc.NAE2026-09-04
08809319802631HyFer HerNonMOON-X USA, Inc.NAE2026-08-03
00850083365011LaviorLavior Pharma Inc.NAE2026-07-17
00850083365028LaviorLavior Pharma Inc.NAE2026-07-17
06970206829191PreviClear Border Sacrum Transparent Gel DressingJiangsu NewValue Medical Products Co.,Ltd.NAE2026-06-23
06970206829207PreviClear Border Sacrum Transparent Gel DressingJiangsu NewValue Medical Products Co.,Ltd.NAE2026-06-23
06970206820808kegel Hydrogel DressingJiangsu NewValue Medical Products Co.,Ltd.NAE2026-06-22
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10840330705810ProCureTwin Med, LLCNAE2026-04-22
10840330706350ProCureTwin Med, LLCNAE2026-04-22
00324357010155Zeni MedicalFocus Health Group, Inc.NAE2026-04-13
00324357100252Zeni MedicalFocus Health Group, Inc.NAE2026-04-13
00324357104045Zeni MedicalFocus Health Group, Inc.NAE2026-04-13
00743537000456First ResponderWATER-JEL TECHNOLOGIES, L.L.C.NAE2026-02-19
00743537000470MilitaryWATER-JEL TECHNOLOGIES, L.L.C.NAE2026-02-19
10197344017508MEDLINEMEDLINE INDUSTRIES, INC.NAE2025-10-23
00858071004478Natural Shield Wound Dressing, 1oz brush onKericure Inc.NAE2025-10-06
00858071004553Natural Shield Wound Dressing, 1oz sprayKericure Inc.NAE2025-10-06
20192253040156KendallCardinal Health 200, LLCNAE2025-09-26
00197998326882Solventum™ Nu-Gel™Solventum Germany GmbHNAE2025-09-22