Identity
- Trade Name
- AsthmaMD FDA UDI
- Generic Name
- Peak flow meter, manual FDA UDI
- Device Name
- Peak Flow Meter FDA UDI
- Model / Reference
- G0001-K001 FDA UDI
- Description
- Peak Flow Meter FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00857818006010 FDA UDI
- FDA Product Code
- BZH FDA UDI
- GMDN Term
- Peak flow meter, manual FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.1860 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
No
FDA UDI
Over-the-Counter
Yes
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: Peak flow meter, manual
AsthmaMD by Genia Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Peak flow meter, manual.
- Mini Wright — CLEMENT CLARKE INTERNATIONAL LIMITED · Class II
- PERSONAL BEST — RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD · Class II
- TruPeak® — MONAGHAN MEDICAL CORP. · Class II
- Strive® — MONAGHAN MEDICAL CORP. · Class II
- OVAL MOUTHPIECE — RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD · Class II
- TruZone® — MONAGHAN MEDICAL CORP. · Class II
- ASTHMA CHECK — RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD · Class II
- PLASTIC PEDIATRIC DISPOSABLE MOUTHPIECE — RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Genia Medical, Inc.
Sources (1)
- FDA UDI edd50f6a-d602-4881-a459-61e3af1625c4 33 fields · synced Jun 9, 2026