← Back to catalogue

Hydro-Therm Hme With Luer Port

FDA UDI

Class I (US FDA UDI)

by Intersurgical Incorporated

Identity

Trade Name
HYDRO-THERM HME WITH LUER PORT FDA UDI
Generic Name
Heat/moisture exchanger, single-use FDA UDI
Device Name
HYDRO-THERM HME WITH LUER PORT FDA UDI
Model / Reference
1855000 FDA UDI
Description
HYDRO-THERM HME WITH LUER PORT FDA UDI

Identifiers

Primary DI / UDI-DI
05030267055692 FDA UDI
FDA Product Code
BYD FDA UDI
GMDN Term
Heat/moisture exchanger, single-use FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
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

No

FDA UDI

Combination Product

Yes

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

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-use

Hydro-Therm Hme With Luer Port by Intersurgical Incorporated — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Heat/moisture exchanger, single-use.

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
Intersurgical Incorporated

Sources (1)

  • FDA UDI 4e7444e8-92d3-4abf-8734-c0e20889ba84 34 fields · synced May 30, 2026