Dar

FDA UDI

Class II (US FDA UDI)

by Covidien LP

Identity

Trade Name: DAR FDA UDI
Generic Name: Heat/moisture exchanger insertable filter FDA UDI
Device Name: Adult-Pediatric Electrostatic Filter HME with Catheter Mount,Large FDA UDI
Model / Reference: 352/5815 FDA UDI
Description: Adult-Pediatric Electrostatic Filter HME with Catheter Mount,Large FDA UDI

Identifiers

Primary DI / UDI-DI: 20884522038444 FDA UDI
FDA Product Code: CAH FDA UDI
GMDN Term: Heat/moisture exchanger insertable filter FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 868.5260 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Heat/moisture exchanger insertable filter

Dar by Covidien LP — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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HYPO FILTER — Resmed Corp · Class II
SPIRO — Fogless International AB · Class II
AirMini Filter — RESMED PTY LTD · Class II
HME Filters — CORVENT MEDICAL, INC · Class II

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Covidien LP

Sources (1)

FDA UDI d490ce1b-a09c-4bda-b11c-b773553d1400 35 fields · synced May 30, 2026