Identity
- Trade Name
- DualSeal Chest Seals FDA UDI
- Generic Name
- Pneumothorax dressing FDA UDI
- Device Name
- DualSeal Chest Seals, a pack of two 4" x 4" fully occlusive hydrogel dressings for sealing multiple open chest wounds and reducing the risk of tension pneumothorax FDA UDI
- Model / Reference
- 1 FDA UDI
- Description
- DualSeal Chest Seals, a pack of two 4" x 4" fully occlusive hydrogel dressings for sealing multiple open chest wounds and reducing the risk of tension pneumothorax FDA UDI
Identifiers
- Catalog Number
- HHDSK01 FDA UDI
- Primary DI / UDI-DI
- 00857048006378 FDA UDI
- FDA Product Code
- NAE FDA UDI
- GMDN Term
- Pneumothorax dressing FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4022 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Pneumothorax dressing
DualSeal Chest Seals by H & H Medical Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Pneumothorax dressing.
- SAM Chest Seal — SAM Medical Products · Class I
- SAM Chest Seal — SAM Medical Products · Class I
- NAR — NORTH AMERICAN RESCUE, LLC. · Class I
- FOXSEAL — Medtrade Products , Ltd. · Class I
- FOXSEAL Vented — Medtrade Products , Ltd. · Class I
- Chest Wound Seal Kit — SAFEGUARD US OPERATING, LLC · Class I
- Russell Chest Seal (US Version) — SAFEGUARD MEDICAL TECHNOLOGIES LIMITED · Class I
- Sentinel Chest Seal — SAFEGUARD US OPERATING, LLC · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- H & H Medical Corporation
Sources (1)
- FDA UDI 5e667f42-e196-4efc-bf18-e341df0b06b3 35 fields · synced May 30, 2026