Aero-Sat

GUDID 10841470107984

ENGINEERED MEDICAL SYSTEMS INC

Heat/moisture exchanger/microbial medical gas filter
Primary Device ID10841470107984
NIH Device Record Key0897bd98-ef43-4451-b15d-a2cbf82a4458
Commercial Distribution StatusIn Commercial Distribution
Brand NameAero-Sat
Version Model Number301-437
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
GS100841470107987 [Primary]
GS110841470107984 [Package]
Contains: 00841470107987
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-Sat]

10841470108073301-424
00841470108007301-423
00841470107994301-427
10841470107984301-437
00841470106317301-422
00841470103453301-414
10841470103443301-413

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