Y-piece 7/5 mm Disposable System

GUDID 07612367015301

Y-Piece for disposable system

Medela AG

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Primary Device ID07612367015301
NIH Device Record Key37cad0a9-5391-490b-8723-5a0b3efbb05a
Commercial Distribution StatusIn Commercial Distribution
Brand NameY-piece 7/5 mm Disposable System
Version Model Number077.0097
Company DUNS488293218
Company NameMedela AG
Device Count10
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 Batchfalse
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1-877-735-1626
Emailinfo-healthcare@medela.com
Phone+1-877-735-1626
Emailinfo-healthcare@medela.com
Phone+1-877-735-1626
Emailinfo-healthcare@medela.com
Phone+1-877-735-1626
Emailinfo-healthcare@medela.com
Phone+1-877-735-1626
Emailinfo-healthcare@medela.com
Phone+1-877-735-1626
Emailinfo-healthcare@medela.com
Phone+1-877-735-1626
Emailinfo-healthcare@medela.com
Phone+1-877-735-1626
Emailinfo-healthcare@medela.com
Phone+1-877-735-1626
Emailinfo-healthcare@medela.com
Phone+1-877-735-1626
Emailinfo-healthcare@medela.com
Phone+1-877-735-1626
Emailinfo-healthcare@medela.com
Phone+1-877-735-1626
Emailinfo-healthcare@medela.com
Phone+1-877-735-1626
Emailinfo-healthcare@medela.com
Phone+1-877-735-1626
Emailinfo-healthcare@medela.com
Phone+1-877-735-1626
Emailinfo-healthcare@medela.com
Phone+1-877-735-1626
Emailinfo-healthcare@medela.com
Phone+1-877-735-1626
Emailinfo-healthcare@medela.com
Phone+1-877-735-1626
Emailinfo-healthcare@medela.com
Phone+1-877-735-1626
Emailinfo-healthcare@medela.com
Phone+1-877-735-1626
Emailinfo-healthcare@medela.com
Phone+1-877-735-1626
Emailinfo-healthcare@medela.com
Phone+1-877-735-1626
Emailinfo-healthcare@medela.com
Phone+1-877-735-1626
Emailinfo-healthcare@medela.com
Phone+1-877-735-1626
Emailinfo-healthcare@medela.com
Phone+1-877-735-1626
Emailinfo-healthcare@medela.com
Phone+1-877-735-1626
Emailinfo-healthcare@medela.com
Phone+1-877-735-1626
Emailinfo-healthcare@medela.com
Phone+1-877-735-1626
Emailinfo-healthcare@medela.com
Phone+1-877-735-1626
Emailinfo-healthcare@medela.com
Phone+1-877-735-1626
Emailinfo-healthcare@medela.com
Phone+1-877-735-1626
Emailinfo-healthcare@medela.com
Phone+1-877-735-1626
Emailinfo-healthcare@medela.com
Phone+1-877-735-1626
Emailinfo-healthcare@medela.com
Phone+1-877-735-1626
Emailinfo-healthcare@medela.com
Phone+1-877-735-1626
Emailinfo-healthcare@medela.com
Phone+1-877-735-1626
Emailinfo-healthcare@medela.com
Phone+1-877-735-1626
Emailinfo-healthcare@medela.com
Phone+1-877-735-1626
Emailinfo-healthcare@medela.com
Phone+1-877-735-1626
Emailinfo-healthcare@medela.com
Phone+1-877-735-1626
Emailinfo-healthcare@medela.com
Phone+1-877-735-1626
Emailinfo-healthcare@medela.com

Device Identifiers

Device Issuing AgencyDevice ID
GS107612367015301 [Primary]
GS107612367051354 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

BTAPump, Portable, Aspiration (Manual Or Powered)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number6
Public Version Date2020-05-06
Device Publish Date2016-10-03

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07612367003575 - Change over valve2024-06-10 Change over valve
07612367003698 - Overflow protection device2024-06-10 Overflow protection device
07612367003735 - Reusable serial connector2024-06-10 Reusable serial connector

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