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InHealth Technologies

FDA UDI

Class II (US FDA UDI)

by Freudenberg Medical, Llc

Identity

Trade Name
InHealth Technologies FDA UDI
Generic Name
Heat/moisture exchanger, single-use FDA UDI
Model / Reference
PK 2002-R2 FDA UDI

Identifiers

Primary DI / UDI-DI
00848253001340 FDA UDI
FDA Product Code
JOH FDA UDI
BTO FDA UDI
BTR FDA UDI
BYD FDA UDI
GMDN Term
Heat/moisture exchanger, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
868.5800 FDA UDI
868.5730 FDA UDI
868.5375 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

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: Heat/moisture exchanger, single-useLaryngectomy tube

InHealth Technologies by Freudenberg Medical, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Laryngectomy tube.

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 2ad26938-ea4c-47ac-8158-e3002c1e64b8 33 fields · synced Sep 18, 2026