Freestyle Hands-free

GUDID 07612367080576

Double electric, single user breast pump intended to express & collect breast milk

Medela AG

Breast pump, electric Breast pump, electric Breast pump, electric Breast pump, electric Breast pump, electric Breast pump, electric Breast pump, electric Breast pump, electric Breast pump, electric Breast pump, electric Breast pump, electric Breast pump, electric
Primary Device ID07612367080576
NIH Device Record Key57a3558b-569f-491b-a69d-4f6a2c15fc53
Commercial Distribution StatusIn Commercial Distribution
Brand NameFreestyle Hands-free
Version Model Number101044164
Company DUNS488293218
Company NameMedela AG
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 Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100020451441641 [Primary]
GS107612367080576 [Direct Marking]
GS107612367082198 [Package]
Contains: 00020451441641
Package: [1 Units]
In Commercial Distribution

FDA Product Code

HGXPump, Breast, Powered

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-12-09
Device Publish Date2022-12-01

Devices Manufactured by Medela AG

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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
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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