A-PEP

GUDID 10841470109988

ENGINEERED MEDICAL SYSTEMS INC

In-line CPAP set, non-nebulizing
Primary Device ID10841470109988
NIH Device Record Keyad9916da-a131-4774-b40a-2bd2fc5c37f0
Commercial Distribution StatusIn Commercial Distribution
Brand NameA-PEP
Version Model Number301-6200
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
GS100841470109981 [Primary]
GS110841470109988 [Package]
Contains: 00841470109981
Package: [10 Units]
In Commercial Distribution

FDA Product Code

BYEAttachment, Breathing, Positive End Expiratory Pressure

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-12-20
Device Publish Date2023-12-12

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

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