Identity
- Trade Name
- InHealth Technologies; Blom-Singer FDA UDI
- Generic Name
- Transcervical artificial larynx FDA UDI
- Device Name
- Post-Operative Care Kit with 10/55 Tube & ClassicFlow HME & Electrolarynx FDA UDI
- Model / Reference
- PK 2104 FDA UDI
- Description
- Post-Operative Care Kit with 10/55 Tube & ClassicFlow HME & Electrolarynx FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00848253003436 FDA UDI
- FDA Product Code
- KGX FDA UDIESE FDA UDICBH FDA UDIBYD FDA UDIKAC FDA UDIEWL FDA UDI
- GMDN Term
- Transcervical artificial larynx FDA UDI
- Models / Variants
- InHealth Technologies FDA UDIBlom-Singer FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 880.5240 FDA UDI874.3375 FDA UDI868.5770 FDA UDI868.5375 FDA UDI874.4420 FDA UDI874.3730 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
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, non-sterileRemovable ambulatory appliance skin-adherent patchTranscervical artificial larynx
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 Tracheostomy base plate, reusable.
- InHealth Technologies; Blom-Singer — FREUDENBERG MEDICAL, LLC · Class I
- InHealth Technologies; Blom-Singer — FREUDENBERG MEDICAL, LLC · Class I
- InHealth Technologies; Blom-Singer — FREUDENBERG MEDICAL, LLC · Class I
- InHealth Technologies; Blom-Singer — FREUDENBERG MEDICAL, LLC · Class II
- InHealth Technologies; Blom-Singer — FREUDENBERG MEDICAL, LLC · Class II
- InHealth Technologies; Blom-Singer — FREUDENBERG MEDICAL, LLC · Class II
- InHealth Technologies; Blom-Singer — FREUDENBERG MEDICAL, LLC · Class I
- InHealth Technologies; Blom-Singer — FREUDENBERG MEDICAL, LLC · 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 |
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Manufacturer
- Manufacturer
- Freudenberg Medical, Llc
Sources (1)
- FDA UDI dec521c4-45b6-42d4-be99-611e01bf0ef9 34 fields · synced Sep 18, 2026