Identity
- Trade Name
- Disposable Spirometer Mouthpieces FDA UDI
- Generic Name
- Breathing mouthpiece, single-use FDA UDI
- Device Name
- Disposable mouthpiece FDA UDI
- Model / Reference
- 2-100-1205 FDA UDI
- Description
- Disposable mouthpiece FDA UDI
Identifiers
- Catalog Number
- 2-100-1205 FDA UDI
- Primary DI / UDI-DI
- 10841709100359 FDA UDI
- FDA Product Code
- BZG FDA UDI
- GMDN Term
- Breathing mouthpiece, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.1840 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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Breathing mouthpiece, single-use
Disposable Spirometer Mouthpieces by Midmark Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
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
- Midmark Corporation
Sources (1)
- FDA UDI d5d020a3-b15e-40ab-be79-43697a51513d 36 fields · synced Jun 8, 2026