ResMed AirSense 11 Style Filters

GUDID 00848530096465

Resmed Airsense 11 CPAP Filter

SUNSET HEALTHCARE SOLUTIONS, INC.

CPAP/BPAP unit ambient air filter, single-use
Primary Device ID00848530096465
NIH Device Record Keyac3252e3-0e77-42a5-94d6-0cc873d72d22
Commercial Distribution StatusIn Commercial Distribution
Brand NameResMed AirSense 11 Style Filters
Version Model NumberCF2111-2
Company DUNS141668116
Company NameSUNSET HEALTHCARE SOLUTIONS, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100848530096465 [Primary]

FDA Product Code

JRLUnit, Filter, Membrane

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-06-21
Device Publish Date2024-06-13

On-Brand Devices [ResMed AirSense 11 Style Filters]

10848530103795Resmed Airsense 11 CPAP Filter - 3/Pack
00848530096465Resmed Airsense 11 CPAP Filter

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