Identity
- Trade Name
- Penetrating Chest Injury Kit FDA UDI
- Generic Name
- Pneumothorax dressing FDA UDI
- Device Name
- H&H Penetrating Chest Injury Kit, containing one Bolin Chest Seal and one Wound Seal Kit, for the treatment of entry and exit chest wounds to reduce the risk of tension pneumothorax. FDA UDI
- Model / Reference
- 1 FDA UDI
- Description
- H&H Penetrating Chest Injury Kit, containing one Bolin Chest Seal and one Wound Seal Kit, for the treatment of entry and exit chest wounds to reduce the risk of tension pneumothorax. FDA UDI
Identifiers
- Catalog Number
- HHPCIK01 FDA UDI
- Primary DI / UDI-DI
- 00857048006170 FDA UDI
- FDA Product Code
- NAD FDA UDI
- GMDN Term
- Pneumothorax dressing FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4020 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
Penetrating Chest Injury Kit by H & H Medical Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Pneumothorax dressing.
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- 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 7c87ca7e-5dc8-4688-882d-5e3c2fa0e4cd 35 fields · synced May 30, 2026