Disposable bacteria /odour filter

GUDID 07612367031639

Medela AG

Suction system filter, microbial
Primary Device ID07612367031639
NIH Device Record Keye724ad79-dbb5-4fbc-8a98-14d28858b059
Commercial Distribution StatusIn Commercial Distribution
Brand NameDisposable bacteria /odour filter
Version Model Number077.0576
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

Device Identifiers

Device Issuing AgencyDevice ID
GS107612367004190 [Primary]
GS107612367031639 [Package]
Contains: 07612367004190
Package: [20 Units]
In Commercial Distribution
GS107612367051200 [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 Number3
Public Version Date2018-07-06
Device Publish Date2016-10-03

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07612367038713 - Standard rail universal holder2024-06-11 Universal clamp with standard rail
07612367000109 - Silicone tubing ID 6.5mm, 180cm, 1 coupling piece2024-06-10 Silicone tubing ID 6.5mm, 180cm, 1 coupling piece

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