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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
Tracheostomy tube neck holder, reusable FDA UDI
Device Name
Post-Operative Care Kit with 10/55 Tube & EasyFlow HME FDA UDI
Model / Reference
PK 2103 FDA UDI
Description
Post-Operative Care Kit with 10/55 Tube & EasyFlow HME FDA UDI

Identifiers

Primary DI / UDI-DI
00848253003429 FDA UDI
FDA Product Code
EWL FDA UDI
KAC FDA UDI
BYD FDA UDI
CBH FDA UDI
KGX FDA UDI
GMDN Term
Tracheostomy tube neck holder, reusable 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
874.4420 FDA UDI
868.5375 FDA UDI
868.5770 FDA UDI
880.5240 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-useLaryngectomy tube, non-sterileRemovable ambulatory appliance skin-adherent patchTracheostomy tube neck holder, reusable

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.

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 08e5ac47-65fa-41f4-a8cc-11340912a25e 34 fields · synced Sep 18, 2026