Identity
- Trade Name
- Tension Pneumothorax Kit w/ Capnospot FDA UDI
- Generic Name
- Pneumothorax catheter insertion set FDA UDI
- Device Name
- The Advanced Tension Pneumothorax Kit from TacMed Solutions™ provides for state-of-the-art placement of needle thoracostomy using evidence-based equipment for surface anatomy, durable and reliable decompression, and decompression indicators more accurate than current standard of care auditory assessments. The Advanced kit features Capnospot® which lets you know you're in by offering objective, visual confirmation. FDA UDI
- Model / Reference
- A FDA UDI
- Description
- The Advanced Tension Pneumothorax Kit from TacMed Solutions™ provides for state-of-the-art placement of needle thoracostomy using evidence-based equipment for surface anatomy, durable and reliable decompression, and decompression indicators more accurate than current standard of care auditory assessments. The Advanced kit features Capnospot® which lets you know you're in by offering objective, visual confirmation. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00818630016328 FDA UDI
- FDA Product Code
- GAA FDA UDI
- GMDN Term
- Pneumothorax catheter insertion set FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Pneumothorax catheter insertion set
Tension Pneumothorax Kit w/ Capnospot by Tactical Medical Solutions, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Tactical Medical Solutions, Llc
Sources (1)
- FDA UDI 825b9105-bfe4-4965-86ea-fe859caa4446 33 fields · synced Jun 1, 2026