FDA.reportPublic FDA data

AccuPAP

Primary DI
00841470108212
Brand
AccuPAP
Company
ENGINEERED MEDICAL SYSTEMS INC
Model
301-6002
Published
2018-08-24
Public version status
Update
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10841470108219PackageGS110In Commercial Distribution
00841470108212PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084147010821910841470108219
00841470108212008414701082128414701082120841470108212

GMDN Terms#

Term, Definition table
TermDefinition
In-line CPAP set, non-nebulizingA portable collection of devices intended to be connected to a medical gas supply to assist non-intubated ventilation (i.e., without an artificial airway) using continuous positive airway pressure (CPAP) during spontaneous patient respiration in respiratory emergency situations and/or respiratory therapy settings. It includes an in-line/gas-line CPAP device (a small plastic unit intended to establish a gas pressure proportional to gas flow rate), a mouthpiece or face mask, and may include additional components (e.g., tubing, manometer gauge); it does not include a nebulizer. This is a single-patient, reusable device.

Regulatory Flags#

DUNS number
154502934
Device count
1
Lot or batch
true
Expiration date on label
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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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00810094578022Curaplex®BOUND TREE MEDICAL, LLCBYE2025-07-09
00810094578039Curaplex®BOUND TREE MEDICAL, LLCBYE2025-07-09
00810094578046Curaplex®BOUND TREE MEDICAL, LLCBYE2025-07-09
00026072001479EMAllied Medical, LLCBYE2024-05-28
00810094574987CuraplexBOUND TREE MEDICAL, LLCBYE2023-02-28
00810094575007CuraplexBOUND TREE MEDICAL, LLCBYE2023-02-28
00810094574994CuraplexBOUND TREE MEDICAL, LLCBYE2023-02-28
00810094575014CuraplexBOUND TREE MEDICAL, LLCBYE2023-02-28
10884521831643ShileyCovidien LPBYE2023-02-18
10884521831636ShileyCovidien LPBYE2023-02-16
00810071637261CuraplexBOUND TREE MEDICAL, LLCBYE2022-12-30
00810071637278CuraplexBOUND TREE MEDICAL, LLCBYE2022-12-30
00709078013560Bracket with Tube GuideWESTMED, INC.BYE2021-10-15
00709078013546WaterPAP Pole ClampWESTMED, INC.BYE2021-10-08
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00709078013195WaterPAPWESTMED, INC.BYE2021-08-31
10641043574041Flow-Safe II+ BiLevel Disposable CPAP SystemMERCURY ENTERPRISES, INC.BYE2021-01-14
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10641043572467Flow-Safe II Disposable CPAP SystemMERCURY ENTERPRISES, INC.BYE2020-11-12
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08498840012130VYGONVygon CorporationBYE2020-03-12
15019315061066PortexICU MEDICAL, INC.BYE2020-03-12
15019315061073PortexICU MEDICAL, INC.BYE2020-03-12