Identity
- Trade Name
- InHealth Technologies; Blom-Singer FDA UDI
- Generic Name
- Laryngectomy tube, non-sterile FDA UDI
- Model / Reference
- BE 6303 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00813307011972 FDA UDI
- FDA Product Code
- KAC FDA UDI
- GMDN Term
- Laryngectomy tube, non-sterile FDA UDI
- Models / Variants
- InHealth Technologies FDA UDIBlom-Singer FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 874.4420 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: Laryngectomy tube, non-sterile
InHealth Technologies +1 more model by Freudenberg Medical, Llc — Class I — FDA UDI — listed in FDA GUDID — 2 models — regulatory data on deviCERTS
Similar devices
Also classified as Laryngectomy tube, non-sterile.
- Invotec Tracheal T-Tube — Invotec International, Inc. · Class II
- Invotec Tracheal T-Tube — Invotec International, Inc. · Class II
- Invotec Tracheal T-Tube — Invotec International, Inc. · Class II
- Invotec Tracheal T-Tube — Invotec International, Inc. · Class II
- Bausch + Lomb — Bausch & Lomb Incorporated · Class I
- Invotec Tracheal T-Tube — Invotec International, Inc. · Class II
- InHealth Technologies; Blom-Singer; StomaSoft — FREUDENBERG MEDICAL, LLC · Class I
- InHealth Technologies; Blom-Singer; StomaSoft — FREUDENBERG MEDICAL, LLC · 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Freudenberg Medical, Llc
Sources (1)
- FDA UDI 4e27c6d5-30e9-46f7-a1d1-9af43f04df0a 33 fields · synced Sep 18, 2026