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ResMed S9 and AirSense 10 Style Hypoallergenic Filters

FDA UDI

Class II (US FDA UDI)

by SUNSET HEALTHCARE SOLUTIONS, Inc.

Identity

Trade Name
ResMed S9 and AirSense 10 Style Hypoallergenic Filters FDA UDI
Generic Name
Surgical suction system collection container, single-use FDA UDI
Device Name
ResMed S9 and AirSense 10 Style Hypoallergenic Filters (2/pack) FDA UDI
Model / Reference
CF2107HA-2 FDA UDI
Description
ResMed S9 and AirSense 10 Style Hypoallergenic Filters (2/pack) FDA UDI

Identifiers

Catalog Number
CF2107HA-2 FDA UDI
Primary DI / UDI-DI
00848530036034 FDA UDI
FDA Product Code
GCX FDA UDI
GMDN Term
Surgical suction system collection container, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
880.6740 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

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

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

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Surgical suction system collection container, single-use

ResMed S9 and AirSense 10 Style Hypoallergenic Filters by SUNSET HEALTHCARE SOLUTIONS, Inc. — Class II — FDA UDI — listed in FDA GUDID

Similar devices

Also classified as Surgical suction system collection container, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
SUNSET HEALTHCARE SOLUTIONS, Inc.

Sources (1)

  • FDA UDI 89373bd6-c0dc-4bfa-b5ce-a9da07bf63e3 37 fields · synced May 30, 2026