← Back to catalogue

InHealth Technologies +1 more model

FDA UDI

Class II (US FDA UDI)

by Freudenberg Medical, Llc

Identity

Trade Name
InHealth Technologies; Blom-Singer® FDA UDI
Generic Name
Tracheostomy tube speech valve FDA UDI
Device Name
Blom-Singer® FirstFit Surgical Kit with 16Fr Classic Indwelling Voice Prosthesis, 12mm length FDA UDI
Model / Reference
TP 1612 FDA UDI
Description
Blom-Singer® FirstFit Surgical Kit with 16Fr Classic Indwelling Voice Prosthesis, 12mm length FDA UDI

Identifiers

Primary DI / UDI-DI
00848253002361 FDA UDI
FDA Product Code
EWL FDA UDI
GMDN Term
Tracheostomy tube speech valve FDA UDI
Models / Variants
InHealth Technologies FDA UDI
Blom-Singer® FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
874.3730 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

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: Tracheostomy tube speech valveTracheoesophageal speech valve guidewire

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 Tracheoesophageal speech valve guidewire.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Freudenberg Medical, Llc

Sources (1)

  • FDA UDI 3c9db17b-3c23-41e0-afa1-186857721fe0 34 fields · synced Sep 18, 2026