APV- Adjustable PEEP Valve

GUDID 10841470111431

ENGINEERED MEDICAL SYSTEMS INC

PEEP valve, single-use
Primary Device ID10841470111431
NIH Device Record Key9c6c3035-45b4-4ada-9f4b-b9a6c34e39af
Commercial Distribution StatusIn Commercial Distribution
Brand NameAPV- Adjustable PEEP Valve
Version Model Number301-5584
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 Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100841470111434 [Primary]
GS110841470111431 [Package]
Contains: 00841470111434
Package: [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

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 Date2024-06-17
Device Publish Date2024-06-07

Devices Manufactured by ENGINEERED MEDICAL SYSTEMS INC

10841470111431 - APV- Adjustable PEEP Valve2024-06-17
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
00841470100230 - Pulmonary Function Filter2023-12-19
10841470100985 - Aero-Pro2023-12-19

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