Pulmonary Function Filter

GUDID 00841470100230

ENGINEERED MEDICAL SYSTEMS INC

Pulmonary function testing kit
Primary Device ID00841470100230
NIH Device Record Key7f64dab1-359b-44f9-ba37-b8eed6cffb1a
Commercial Distribution StatusIn Commercial Distribution
Brand NamePulmonary Function Filter
Version Model Number301-436
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
GS100841470100230 [Primary]
GS110841470100237 [Package]
Package: [50 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

BZGSpirometer, Diagnostic

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

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10841470108356 - FENEM2023-12-20
10841470108370 - FENEM2023-12-20
10841470109988 - A-PEP2023-12-20
10841470111196 - DPM2023-12-20
10841470100220 - Bacterial/Viral Filter2023-12-19
00841470100230 - Pulmonary Function Filter2023-12-19
00841470100230 - Pulmonary Function Filter2023-12-19
10841470100985 - Aero-Pro2023-12-19

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