Identity
- Trade Name
- MABIS FDA UDI
- Generic Name
- Nebulizing system delivery set, reusable FDA UDI
- Device Name
- MINICOMP COMPRESSOR NEBULIZER W/CASE FDA UDI
- Model / Reference
- 40-126-000 FDA UDI
- Description
- MINICOMP COMPRESSOR NEBULIZER W/CASE FDA UDI
Identifiers
- Catalog Number
- 40-126-000 FDA UDI
- Primary DI / UDI-DI
- 00767056401266 FDA UDI
- 510(k) Number
- K031413 FDA UDI
- FDA Product Code
- CAF FDA UDI
- GMDN Term
- Nebulizing system delivery set, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5630 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
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Mabis by Dms Holdings, Inc., — 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
- Dms Holdings, Inc.,
Sources (1)
- FDA UDI cc50804d-627a-49c6-be60-6b8997833618 36 fields · synced Jun 1, 2026