S9

FDA UDI

Class II (US FDA UDI)

by Resmed Pty Ltd

Identity

Trade Name: S9 FDA UDI
Generic Name: Heat/moisture exchanger insertable filter FDA UDI
Device Name: S9/ AIR10 FILTER, HYPO 1 PACK FDA UDI
Model / Reference: 36855 FDA UDI
Description: S9/ AIR10 FILTER, HYPO 1 PACK FDA UDI

Identifiers

Catalog Number: 36855 FDA UDI
Primary DI / UDI-DI: 00619498368556 FDA UDI
FDA Product Code: BZD FDA UDI
GMDN Term: Heat/moisture exchanger insertable filter FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 868.5905 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

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

FDA UDI

Manufacturing Date

FDA UDI

Category: Heat/moisture exchanger insertable filter

S9 by Resmed Pty Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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DAR — Covidien LP · Class II
HME Filters — CORVENT MEDICAL, INC · Class II
BV Filters — CORVENT MEDICAL, INC · Class II
Resp-O2 Advantage Filter- Universal Respiratory B/V Filter — Dynarex Corp. · 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: Resmed Pty Ltd

Sources (1)

FDA UDI a582c861-8a8e-4110-9fd0-b0e4ce1c595b 36 fields · synced Jun 1, 2026