Identity
- Trade Name
- ChoiceMMed FDA UDI
- Generic Name
- Respiratory muscle training mask FDA UDI
- Device Name
- ChoiceMMed LungBoost Respiratory Trainer MD8000 FDA UDI
- Model / Reference
- MD8000 FDA UDI
- Description
- ChoiceMMed LungBoost Respiratory Trainer MD8000 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00846841030147 FDA UDI
- FDA Product Code
- ION FDA UDI
- GMDN Term
- Respiratory muscle training mask FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 890.5370 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
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Respiratory muscle training mask
ChoiceMMed by Beijing Choice Electronic Technology Co., Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Respiratory muscle training mask.
- Medex — ICU MEDICAL, INC. · Class I
- Aerosure — Actegy , 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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Beijing Choice Electronic Technology Co., Ltd.
Sources (1)
- FDA UDI 31688640-64da-42ca-a0f2-0c856c51638b 33 fields · synced May 30, 2026