Identity
- Trade Name
- VORTRAN Medical Air Compressor FDA UDI
- Generic Name
- Medical device air compressor FDA UDI
- Device Name
- The VORTRAN Medical Air Compressor is a compressor designed for continuous, high pressure performance, easy and practical for home and hospital uses. It is capable of servicing nebulizer and humidifiers to product particle aerosol mist. FDA UDI
- Model / Reference
- 8100 FDA UDI
- Description
- The VORTRAN Medical Air Compressor is a compressor designed for continuous, high pressure performance, easy and practical for home and hospital uses. It is capable of servicing nebulizer and humidifiers to product particle aerosol mist. FDA UDI
Identifiers
- Catalog Number
- 8100 FDA UDI
- Primary DI / UDI-DI
- 10637320081005 FDA UDI
- 510(k) Number
- K072634 FDA UDI
- FDA Product Code
- BTI FDA UDI
- GMDN Term
- Medical device air compressor FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.6250 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Medical device air compressor
VORTRAN Medical Air Compressor by Vortran Medical Technology 1, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K072634 also covers:
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 II | Pending data |
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Manufacturer
- Manufacturer
- Vortran Medical Technology 1, Inc.
Sources (1)
- FDA UDI 2ab63847-dfe6-40f4-8645-bab4b0145342 36 fields · synced May 31, 2026