N/A

Primary DI
06923980114342
Brand
N/A
Company
GaleMed Xiamen Co., Ltd.
Model
XML0004
Device description
PEEP Valve, 5-20cmH2O, 30F w/adapter
Published
2024-09-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
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
K133957000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K133957000DISPOSABLE ADJUSTABLE PEEP VALVE MR CONDITIONAL USEGalemed Corp.2014-04-14BYE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
46923980114340PackageGS110In Commercial Distribution
06923980114342PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
4692398011434046923980114340
06923980114342069239801143426923980114342

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
527333326
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06923980111907MindrayXMR00512026-05-26
06923980112546MindrayXMR00662026-05-26
06923980112577MindrayXMR00242026-05-26
06923980112584MindrayXMR00262026-05-26
06923980112591MindrayXMR01012026-05-26
06923980112607MindrayXMR01022026-05-26
06923980112614MindrayXMR00522026-05-26
06923980112621MindrayXMR00532026-05-26
06923980112638MindrayXMR00812026-05-26
06923980112690MindrayXMR01042026-05-26
06923980112799MindrayXMR00582026-05-26
06923980112805MindrayXMR00442026-05-26
06923980112829MindrayXMR00462026-05-26
06944904007236MindrayXMR00862026-05-26
16923980111843MindrayXMR02302026-05-26
06923980112522MindrayXMR00112026-05-25
06923980112539MindrayXMR00122026-05-25
06923980112553MindrayXMR00212026-05-25
06923980112560MindrayXMR00232026-05-25
06923980112645MindrayXMR00152026-05-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810094578534Curaplex®BOUND TREE MEDICAL, LLCBYE2025-08-06
00810094578008Curaplex®BOUND TREE MEDICAL, LLCBYE2025-07-09
00810094578015Curaplex®BOUND TREE MEDICAL, LLCBYE2025-07-09
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
00709078013607WaterPAP™ Starter KitWESTMED, INC.BYE2021-10-08
00709078013621WaterPAP™ Pro Starter KitWESTMED, INC.BYE2021-10-08
00709078013195WaterPAPWESTMED, INC.BYE2021-08-31
10641043574041Flow-Safe II+ BiLevel Disposable CPAP SystemMERCURY ENTERPRISES, INC.BYE2021-01-14
10641043574058Flow-Safe II+ BiLevel Disposable CPAP SystemMERCURY ENTERPRISES, INC.BYE2021-01-14
10641043572443Flow-Safe II Disposable CPAP SystemMERCURY ENTERPRISES, INC.BYE2020-11-12
10641043572450Flow-Safe II Disposable CPAP SystemMERCURY ENTERPRISES, INC.BYE2020-11-12
10641043572467Flow-Safe II Disposable CPAP SystemMERCURY ENTERPRISES, INC.BYE2020-11-12
08498840012130VYGONVygon CorporationBYE2020-03-12
15019315061066PortexICU MEDICAL, INC.BYE2020-03-12
15019315061073PortexICU MEDICAL, INC.BYE2020-03-12
15019315061080PortexICU MEDICAL, INC.BYE2020-03-12
10190752133181AirLife™AIRLIFEBYE2020-01-15