Identity
- Trade Name
- Breather Fit FDA UDI
- Generic Name
- Tongue/lip exerciser FDA UDI
- Model / Reference
- B-Fit FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00865202000148 FDA UDI
- FDA Product Code
- ION FDA UDI
- GMDN Term
- Tongue/lip exerciser 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
Yes
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Tongue/lip exerciser
Breather Fit by PN Medical Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Tongue/lip exerciser.
- Breather X — PN Medical Inc · Class I
- The Breather — PN Medical Inc · Class I
- Breather Voice — PN Medical Inc · Class I
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 |
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Manufacturer
- Manufacturer
- PN Medical Inc
Sources (1)
- FDA UDI 604e7e3e-268a-47ab-92b7-f3eed5a14f27 32 fields · synced Jun 6, 2026