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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
Tracheoesophageal device introducer FDA UDI
Model / Reference
BK 4100 FDA UDI

Identifiers

Primary DI / UDI-DI
00813307011613 FDA UDI
FDA Product Code
EWL FDA UDI
GMDN Term
Tracheoesophageal device introducer 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

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

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: Tracheoesophageal device introducerTracheoesophageal speech valve occluder, valved

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 device introducer.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Freudenberg Medical, Llc

Sources (1)

  • FDA UDI c00d2648-36cd-4c71-9988-88433c5e3cec 33 fields · synced Oct 6, 2026