Babi.Plus Bubble PAP Valve 0-10cmH2O

GUDID 44710810100794

Distributed by Teleflex

GALEMED CORPORATION

PEEP valve, reusable
Primary Device ID44710810100794
NIH Device Record Key3eab8646-870d-47bc-807a-60b642c4f5e6
Commercial Distribution StatusIn Commercial Distribution
Brand NameBabi.Plus
Version Model NumberBC01-HD
Catalog NumberBubble PAP Valve 0-10cmH2O
Company DUNS656854379
Company NameGALEMED CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104710810100796 [Primary]
GS124710810100790 [Package]
Contains: 04710810100796
Package: Box [12 Units]
In Commercial Distribution
GS144710810100794 [Package]
Contains: 24710810100790
Package: Carton [2 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

BYEAttachment, Breathing, Positive End Expiratory Pressure

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-09-24

On-Brand Devices [Babi.Plus]

44710810093577BC01-AU
44710810119741B024
44710810119734B023
44710810119727B022
44710810119710B021
44710810119703B020
44710810100800Distributed by Teleflex
44710810100794Distributed by Teleflex
04710810093579BC01-AU
44710810093560BC23-AU
44710810117525PA01
44710810093553BC51-AU
04710810105265BC01-AU

Trademark Results [Babi.Plus]

Mark Image

Registration | Serial
Company
Trademark
Application Date
BABI.PLUS
BABI.PLUS
77642836 3764949 Live/Registered
GALEMED CORPORATION
2009-01-03

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