FDA.reportPublic FDA data

APV- Adjustable PEEP Valve

Primary DI
00841470111434
Brand
APV- Adjustable PEEP Valve
Company
ENGINEERED MEDICAL SYSTEMS INC
Model
301-5584
Published
2024-06-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
BYEAttachment, Breathing, Positive End Expiratory Pressure

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BYEAttachment, Breathing, Positive End Expiratory PressureAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K983920000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K983920000EMS PEEP VALVES- ADJUSTABLEEngineered Medical Systems1999-01-22BYE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10841470111431PackageGS110In Commercial Distribution
00841470111434PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084147011143110841470111431
00841470111434008414701114348414701114340841470111434

GMDN Terms#

Term, Definition table
TermDefinition
PEEP valve, single-useA non-sterile device used in a respiratory or anaesthesia breathing circuit or system to maintain a selected level of positive end expiratory pressure (PEEP) in a patient's airway during ventilation. The device is typically constructed of plastic and metal materials, and has a valve(s) actuated with a spring(s) to provide the airway resistance, and an adjustable knob or dial (usually graduated) to adjust the resistance level typically between 5 to 20 cmH2O. It is used with ventilators, stand-alone breathing systems for oxygen delivery, pulmonary resuscitators, or anaesthetic breathing systems often having an expiratory valve function. This is a single-use device.

Regulatory Flags#

DUNS number
154502934
Device count
1
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841470106218ABC -Flex Tube SystemF060323M3X1E42025-04-11
00841470106263ABC - Uniflow Breathing CircuitU060323M1X1E42025-04-11
00841470106287ABC - Duoflow Bi-lumen Breathing CircuitD072323M2X1E42025-04-11
00841470106348ABC - Flex Tube SystemF060323M0X1E52025-04-11
00841470106577ABC - Compact Breathing CircuitC120323M0X1A42025-04-11
00841470106584ABC - Compact Breathing CircuitC120323M0X1E52025-04-11
00841470106737ABC - Duoflow Bi-lumen Breathing CircuitD072323M0X1A42025-04-11
00841470107116ABC - Uniflow Breathing CircuitU072323M0X1A42025-04-11
00841470107659ABC - Uniflow Breathing CircuitU096323M0X1A42025-04-11
00841470108625ABC - Flex Tube SystemF96M317M0X1A42025-04-11
00841470108731ABC - Duoflow Bi-lumen Breathing CircuitD12M317M1X1A42025-04-11
00841470108847ABC - Pediatric Compact Breathing CircuitPC12123M900002025-04-11
00841470108946ABC - Duoflow Bi-lumen Breathing CircuitD72M317M1X1A42025-04-11
00841470108953ABC - Pediatric Compact Breathing CircuitPC12113M0X5002025-04-11
00841470109455ABC - Compact Breathing CircuitC120323M0X1C52025-04-11
00841470109486ABC - Compact Breathing CircuitC072323M1X1A42025-04-11
00841470109493ABC - Compact Breathing CircuitC120323M1X1E52025-04-11
00841470109509ABC - Duoflow Bi-lumen Breathing CircuitD120323M1X1A42025-04-11
00841470109523ABC - Uniflow Breathing CircuitU072323M0X1002025-04-11
00841470109530ABC - Uniflow Breathing CircuitU072323M0X1E52025-04-11

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