Basic portable 200.5461

GUDID 07612367039604

Powered suction pump 071.0000

Medela AG

General-purpose suction system, line-powered
Primary Device ID07612367039604
NIH Device Record Key5f53140c-1337-4d03-a1aa-b5df55d39e9e
Commercial Distribution StatusIn Commercial Distribution
Brand NameBasic portable
Version Model NumberBasic
Catalog Number200.5461
Company DUNS488293218
Company NameMedela AG
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
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

Device Identifiers

Device Issuing AgencyDevice ID
GS107612367039604 [Primary]

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 Date2016-09-24

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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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