B&B Bubbler

Primary DI
00850008733031
Brand
B&B Bubbler
Company
B&B Medical Technologies
Model
25312
Catalog number
25312
Device description
Water Seal CPAP Valve, 12 units
Published
2019-07-12
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
K133210000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K133210000B&B BUBBLERS & T Medical Technologies, Inc.2014-03-28BYE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850008733031PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850008733031008500087330318500087330310850008733031

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
829743579
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
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00850008733154ET Tape 11020110202023-07-06
00850008733208BODAI NEO2-SAFE11105111052023-07-06
00850008733215BODAI NEO2-SAFE11100111002023-07-06
00850008733260Baby Tape Plus25395253952023-07-06
00850008733277Baby Tape Plus25390253902023-07-06
00850008733185Trachstay11270112702020-03-24
00850008733130Locktite11090110902020-01-29
00850008733093Trachguard11250112502020-01-20
00850008733109Trachguard11255112552020-01-20
00850008733116ET Tape II11015110152020-01-20
00850008733123ET Tape II11010110102020-01-20
00850008733086Universal Bite Block, Adult11160111602019-12-13
00850008733062Stabiltube11060110602019-11-08
00850008733079Stabiltube11065110652019-11-08
00850008733048Accutach Flow Sensor25250252502019-07-18
00850008733055B&B Bubbler25324253242019-07-12
00850008733024HOPE Nebulizer11310113102019-05-17
00850008733000HOPE Nebulizer - Adult Kit11320113202019-05-13
00850008733017HOPE Nebulizer - Pediatric Kit11330113302019-05-13

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