Identity
- Trade Name
- McKesson FDA UDI
- Generic Name
- Medical device air compressor FDA UDI
- Device Name
- Compressor Nebulizer System FDA UDI
- Model / Reference
- 16-3665LT FDA UDI
- Description
- Compressor Nebulizer System FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10612479216904 FDA UDI
- 510(k) Number
- K031413 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
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Medical device air compressor
McKesson by Mckesson Medical-Surgical Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K031413 also covers:
- LEADER — Cardinal Health 110, Inc.
- CARDINAL HEALTH — Cardinal Health 200, LLC
- DRIVEMEDICAL — Drive Devilbiss Healthcare
- DRIVEMEDICAL — Drive Devilbiss Healthcare
- DRIVEMEDICAL — Drive Devilbiss Healthcare
- Drive — Drive Devilbiss Healthcare
- Drive — Drive Devilbiss Healthcare
- Drive — Drive Devilbiss Healthcare
- Drive — Drive Devilbiss Healthcare
- Drive — Drive Devilbiss Healthcare
- JOHN BUNN — GF Health Products, Inc
- JOHN BUNN — GF Health Products, Inc
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Mckesson Medical-Surgical Inc.
Sources (1)
- FDA UDI 231df587-1fdf-486b-9ce5-385deae65cd2 34 fields · synced May 30, 2026