Aero-Pro

GUDID 00841470108021

ENGINEERED MEDICAL SYSTEMS INC

Microbial medical gas filter, single-use
Primary Device ID00841470108021
NIH Device Record Key956206e8-b61d-49eb-b028-4e8a6e0a598d
Commercial Distribution StatusIn Commercial Distribution
Brand NameAero-Pro
Version Model Number301-439
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
GS100841470108021 [Primary]
GS110841470108028 [Package]
Package: [50 Units]
In Commercial Distribution

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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