Identity
- Trade Name
- InHealth Technologies FDA UDI
- Generic Name
- Laryngectomy tube FDA UDI
- Model / Reference
- PK 2005F-R2 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00848253001432 FDA UDI
- FDA Product Code
- BYD FDA UDIBTR FDA UDIBTO FDA UDIJOH FDA UDI
- GMDN Term
- Laryngectomy tube FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 868.5375 FDA UDI868.5730 FDA UDI868.5800 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Heat/moisture exchanger, single-useLaryngectomy tube
InHealth Technologies by Freudenberg Medical, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Laryngectomy tube.
- OSSEOUS — EON MEDITECH PRIVATE LIMITED · Class I
- galemed — Galemed Corp. · Class I
- Singer Laryngectomy Tube — Boston Medical Products, Inc. · Class I
- RUSCH — TELEFLEX INCORPORATED · Class II
- OSSEOUS — EON MEDITECH PRIVATE LIMITED · Class I
- Singer Laryngectomy Tube — Boston Medical Products, Inc. · Class I
- Singer Laryngectomy Tube — Boston Medical Products, Inc. · Class I
- galemed — Galemed Corp. · 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
- Freudenberg Medical, Llc
Sources (1)
- FDA UDI cb70eb43-d75d-4324-9303-a65a9f9109d5 33 fields · synced Sep 18, 2026