Identity
- Trade Name
- InHealth Technologies; Blom-Singer FDA UDI
- Generic Name
- Tracheostomy tube speech valve FDA UDI
- Model / Reference
- BE 8025H FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00813307011774 FDA UDI
- FDA Product Code
- BYD FDA UDI
- GMDN Term
- Tracheostomy tube speech valve FDA UDI
- Models / Variants
- InHealth Technologies FDA UDIBlom-Singer FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 868.5375 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
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Tracheostomy tube speech valve
InHealth Technologies - Blom-Singer by Freudenberg Medical, Llc — Class I — FDA UDI — listed in FDA GUDID — 2 models — regulatory data on deviCERTS
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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
- Freudenberg Medical, Llc
Sources (1)
- FDA UDI 68415a60-e79b-411e-a921-3a0275af6903 33 fields · synced Sep 18, 2026