Aero-Pro

GUDID 10841470100985

ENGINEERED MEDICAL SYSTEMS INC

Heat/moisture exchanger/microbial medical gas filter
Primary Device ID10841470100985
NIH Device Record Key8e5a6220-7e8e-4cec-9fdc-d363e454ca7e
Commercial Distribution StatusIn Commercial Distribution
Brand NameAero-Pro
Version Model Number301-411
Company DUNS154502934
Company NameENGINEERED MEDICAL SYSTEMS INC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
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 Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100841470100988 [Primary]
GS110841470100985 [Package]
Contains: 00841470100988
Package: [50 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

CAHFilter, Bacterial, Breathing-Circuit

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-12-19
Device Publish Date2023-12-11

On-Brand Devices [Aero-Pro]

00841470108021301-439
10841470107137301-431
10841470103757301-418
10841470103436301-412
10841470100985301-411

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