Bacterial/Viral Filter

GUDID 10841470100220

ENGINEERED MEDICAL SYSTEMS INC

Heat/moisture exchanger/microbial medical gas filter
Primary Device ID10841470100220
NIH Device Record Key5a44b976-7a8d-4483-84e2-06ce980a2c4a
Commercial Distribution StatusIn Commercial Distribution
Brand NameBacterial/Viral Filter
Version Model Number301-435
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
GS100841470100223 [Primary]
GS110841470100220 [Package]
Contains: 00841470100223
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

Devices Manufactured by ENGINEERED MEDICAL SYSTEMS INC

10841470111431 - APV- Adjustable PEEP Valve2024-06-17
10841470108356 - FENEM2023-12-20
10841470108370 - FENEM2023-12-20
10841470109988 - A-PEP2023-12-20
10841470111196 - DPM2023-12-20
10841470100220 - Bacterial/Viral Filter2023-12-19
10841470100220 - Bacterial/Viral Filter2023-12-19
00841470100230 - Pulmonary Function Filter2023-12-19
10841470100985 - Aero-Pro2023-12-19

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.