N/A

Primary DI
00856825003203
Brand
N/A
Company
GALEMED CORPORATION
Model
1002
Catalog number
XRL0020
Device description
Bubble PAP Valve with 12.5cmH2O
Published
2026-03-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
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
K090317000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K090317000BABI*PLUS BUBBLE PAP VALVEA Plus Medical2009-05-20BYE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00856825003203PackageGS112In Commercial Distribution
00856825003067PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00856825003203008568250032038568250032030856825003203
00856825003067008568250030678568250030670856825003067

GMDN Terms#

Term, Definition table
TermDefinition
Pressure relief valve, single-useA non-sterile device used to regulate the maximum pressure level in a circuit or system (typically containing gas) where it is essential not to exceed a pre-set maximum pressure. Should this pressure level be exceeded, this device will automatically open and vent the excess pressure from the circuit/system ensuring that an excessive pressure level is not sustained, thereby preventing damage to the patient or a parent device. It is typically used in anaesthesia machines and ventilators forming part of the breathing/gas delivery circuit/system, but may be applied to other functions. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
656854379
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04710810085550N/A71053AB01252026-03-05
24710810110171N/A5428AM00342026-03-05
24710810112458N/A5429AM00352026-03-05
04710810080586N/A3564AD00492026-03-05
04710810080838N/A5313AM00282026-03-05
04710810081781N/A5304AM00942026-03-05
04710810081811N/A5305AM00952026-03-05
04710810082122N/A3565AD00512026-03-05
04710810082252N/A5315AM00302026-03-05
04710810082269N/A5314AM00292026-03-05
04710810082405N/A5311AM00262026-03-05
04710810082412N/A5312AM00272026-03-05
04710810082429N/A5316AM00312026-03-05
04710810082481N/A5306AM00962026-03-05
04710810082962N/A3551AD00022026-03-05
04710810083327N/A74112AC00532026-03-05
04710810084621N/A2339AR00822026-03-05
04710810084669N/A2437AV00022026-03-05
04710810084850N/A75045AC01712026-03-05
04710810084942N/A0015AM00422026-03-05

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