Identity
- Trade Name
- Medquip FDA UDI
- Generic Name
- Therapeutic agent nebulizer, benchtop FDA UDI
- Device Name
- Penguin Compressor Nebulizer, No Bag FDA UDI
- Model / Reference
- MQ6006 FDA UDI
- Description
- Penguin Compressor Nebulizer, No Bag FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00689076349611 FDA UDI
- 510(k) Number
- K031413 FDA UDI
- FDA Product Code
- BTI FDA UDICAF FDA UDI
- GMDN Term
- Therapeutic agent nebulizer, benchtop FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.6250 FDA UDI868.5630 FDA UDI
- Commercial Distribution
- Not 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
Medquip by Drive Devilbiss Healthcare — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 |
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Manufacturer
- Manufacturer
- Drive Devilbiss Healthcare
Sources (1)
- FDA UDI 67fba920-ea57-4046-858c-248e5ada0ab5 35 fields · synced Jun 8, 2026