Breast Pump Kit with Harmony & 80mL container

GUDID 20020451464477

MEDELA, INC.

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Primary Device ID20020451464477
NIH Device Record Key53d5827a-89b9-4e75-ac7a-0a0a755303d4
Commercial Distribution StatusIn Commercial Distribution
Brand NameBreast Pump Kit with Harmony & 80mL container
Version Model Number101046447
Company DUNS052002029
Company NameMEDELA, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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 Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-800-435-8316
Emailcustomer.service@medela.com
Phone1-800-435-8316
Emailcustomer.service@medela.com
Phone1-800-435-8316
Emailcustomer.service@medela.com
Phone1-800-435-8316
Emailcustomer.service@medela.com
Phone1-800-435-8316
Emailcustomer.service@medela.com
Phone1-800-435-8316
Emailcustomer.service@medela.com
Phone1-800-435-8316
Emailcustomer.service@medela.com
Phone1-800-435-8316
Emailcustomer.service@medela.com
Phone1-800-435-8316
Emailcustomer.service@medela.com
Phone1-800-435-8316
Emailcustomer.service@medela.com
Phone1-800-435-8316
Emailcustomer.service@medela.com
Phone1-800-435-8316
Emailcustomer.service@medela.com
Phone1-800-435-8316
Emailcustomer.service@medela.com
Phone1-800-435-8316
Emailcustomer.service@medela.com
Phone1-800-435-8316
Emailcustomer.service@medela.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100020451464473 [Primary]
GS120020451464477 [Package]
Contains: 00020451464473
Package: [10 Units]
In Commercial Distribution

FDA Product Code

OHHBreast Pump Kit

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-05-16
Device Publish Date2024-05-08

Devices Manufactured by MEDELA, INC.

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10020451464562 - 18mm PersonalFit™ Plus Breast shields2024-05-29
10020451464586 - PNSMX Resupply kits2024-05-29
10020451416240 - Solo™2024-05-23
10020451467099 - Swing Maxi™ Hands-free2024-05-22
20020451463623 - Pediatric Breast Pump Kit with Harmony2024-05-16
20020451464477 - Breast Pump Kit with Harmony & 80mL container2024-05-16
20020451464477 - Breast Pump Kit with Harmony & 80mL container2024-05-16

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