AXS Universal Liner Set with Solidifier

GUDID 07612367061858

Contains a disposable collection system liner with a specimen cup.

Medela AG

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Primary Device ID07612367061858
NIH Device Record Key3c943a5a-7f13-43cf-a211-d51cf9e461d6
Commercial Distribution StatusIn Commercial Distribution
Brand NameAXS Universal Liner Set with Solidifier
Version Model Number101035340
Company DUNS488293218
Company NameMedela AG
Device Count3
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
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+1-877-735-1625
Emailinfo-healthcare@medela.com
Phone+1-877-735-1625
Emailinfo-healthcare@medela.com
Phone+1-877-735-1625
Emailinfo-healthcare@medela.com
Phone+1-877-735-1625
Emailinfo-healthcare@medela.com
Phone+1-877-735-1625
Emailinfo-healthcare@medela.com
Phone+1-877-735-1625
Emailinfo-healthcare@medela.com
Phone+1-877-735-1625
Emailinfo-healthcare@medela.com
Phone+1-877-735-1625
Emailinfo-healthcare@medela.com
Phone+1-877-735-1625
Emailinfo-healthcare@medela.com
Phone+1-877-735-1625
Emailinfo-healthcare@medela.com
Phone+1-877-735-1625
Emailinfo-healthcare@medela.com
Phone+1-877-735-1625
Emailinfo-healthcare@medela.com
Phone+1-877-735-1625
Emailinfo-healthcare@medela.com
Phone+1-877-735-1625
Emailinfo-healthcare@medela.com
Phone+1-877-735-1625
Emailinfo-healthcare@medela.com
Phone+1-877-735-1625
Emailinfo-healthcare@medela.com
Phone+1-877-735-1625
Emailinfo-healthcare@medela.com
Phone+1-877-735-1625
Emailinfo-healthcare@medela.com
Phone+1-877-735-1625
Emailinfo-healthcare@medela.com
Phone+1-877-735-1625
Emailinfo-healthcare@medela.com
Phone+1-877-735-1625
Emailinfo-healthcare@medela.com
Phone+1-877-735-1625
Emailinfo-healthcare@medela.com
Phone+1-877-735-1625
Emailinfo-healthcare@medela.com
Phone+1-877-735-1625
Emailinfo-healthcare@medela.com
Phone+1-877-735-1625
Emailinfo-healthcare@medela.com
Phone+1-877-735-1625
Emailinfo-healthcare@medela.com
Phone+1-877-735-1625
Emailinfo-healthcare@medela.com
Phone+1-877-735-1625
Emailinfo-healthcare@medela.com
Phone+1-877-735-1625
Emailinfo-healthcare@medela.com
Phone+1-877-735-1625
Emailinfo-healthcare@medela.com
Phone+1-877-735-1625
Emailinfo-healthcare@medela.com
Phone+1-877-735-1625
Emailinfo-healthcare@medela.com
Phone+1-877-735-1625
Emailinfo-healthcare@medela.com
Phone+1-877-735-1625
Emailinfo-healthcare@medela.com
Phone+1-877-735-1625
Emailinfo-healthcare@medela.com
Phone+1-877-735-1625
Emailinfo-healthcare@medela.com
Phone+1-877-735-1625
Emailinfo-healthcare@medela.com
Phone+1-877-735-1625
Emailinfo-healthcare@medela.com
Phone+1-877-735-1625
Emailinfo-healthcare@medela.com
Phone+1-877-735-1625
Emailinfo-healthcare@medela.com
Phone+1-877-735-1625
Emailinfo-healthcare@medela.com

Device Identifiers

Device Issuing AgencyDevice ID
GS107612367060608 [Primary]
GS107612367061858 [Package]
Contains: 07612367060608
Package: [6 Units]
In Commercial Distribution
GS107612367061865 [Unit of Use]

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 Number4
Public Version Date2020-05-06
Device Publish Date2018-06-07

Devices Manufactured by Medela AG

07612367025133 - Docking Station Adapter for canister 2 L2024-06-11 Adapter to docking station for Thopaz canister 2L
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
07612367003551 - Quiver 280mm2024-06-10 Quiver 280mm
07612367003568 - Quiver 480mm2024-06-10 Quiver 480mm
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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