Identity
- Trade Name
- InHealth Technologies; Blom-Singer FDA UDI
- Generic Name
- Tracheostomy tube neck holder, reusable FDA UDI
- Device Name
- Post-Operative Care Kit with 10/55 Tube & ClassicFlow HME & Voice Prosthesis FDA UDI
- Model / Reference
- PK 2105 FDA UDI
- Description
- Post-Operative Care Kit with 10/55 Tube & ClassicFlow HME & Voice Prosthesis FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00848253003443 FDA UDI
- FDA Product Code
- EWL FDA UDIEPE FDA UDIKAC FDA UDIBYD FDA UDICBH FDA UDIKGX FDA UDI
- GMDN Term
- Tracheostomy tube neck holder, reusable FDA UDI
- Models / Variants
- InHealth Technologies FDA UDIBlom-Singer FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 874.3730 FDA UDI868.5795 FDA UDI874.4420 FDA UDI868.5375 FDA UDI868.5770 FDA UDI880.5240 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-useTracheoesophageal device insertion capsuleTracheoesophageal device introducerTracheoesophageal speech valve, indwelling
InHealth Technologies +1 more model by Freudenberg Medical, Llc — Class II — 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 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
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 II | Pending data |
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Manufacturer
- Manufacturer
- Freudenberg Medical, Llc
Sources (1)
- FDA UDI e647cd43-6d44-4a00-bec5-36f1f3f06459 34 fields · synced Sep 18, 2026