Identity
- Trade Name
- Maxineb Duo FDA UDI
- Generic Name
- Breathing mouthpiece, single-use FDA UDI
- Device Name
- MaxiNeb Duo Mouthpiece FDA UDI
- Model / Reference
- 032-10-079U FDA UDI
- Description
- MaxiNeb Duo Mouthpiece FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05055931118824 FDA UDI
- FDA Product Code
- CAF FDA UDI
- GMDN Term
- Breathing mouthpiece, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5630 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
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
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Breathing mouthpiece, single-use
Maxineb Duo by Flexicare Medical Limited — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Breathing mouthpiece, single-use.
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- All Flow Adult Disp Mthpc. — ALLIANCE TECH MEDICAL, INC. · Class I
- PFT — Vitalograph Ireland, Ltd. · Class II
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
- Flexicare Medical Limited
Sources (1)
- FDA UDI 359d3011-dd88-4161-80e4-f78824c8214e 33 fields · synced Jun 8, 2026