Basic rack 200.5461

GUDID 07612367039628

Powered suction pump 071.0001

Medela AG

General-purpose suction system, line-powered Surgical suction pump Surgical suction pump Surgical suction pump Surgical suction pump Surgical suction pump Surgical suction pump Surgical suction pump Surgical suction pump Surgical suction pump Surgical suction pump Surgical suction pump Surgical suction pump Surgical suction pump
Primary Device ID07612367039628
NIH Device Record Keyddec3988-780a-43c9-81d6-c791d2d289d0
Commercial Distribution StatusIn Commercial Distribution
Brand NameBasic rack
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
GS107612367039628 [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

Devices Manufactured by Medela AG

30020451458916 - Invia Motion 15 Days Kit 10 x 10 cm2023-09-11 Invia Motion and Invia Integrated Dressing S Convenience Kit
30020451458923 - Invia Motion 15 Days Kit 10 x 15 cm2023-09-11 Invia Motion and Invia Integrated Dressing M Convenience Kit
30020451458930 - Invia Motion 15 Days Kit 10 x 25 cm2023-09-11 Invia Motion and Invia Integrated Dressing L Convenience Kit
07612367016131 - Vario 18 AC/DC2023-08-15 Powered suction pump
07612367016308 - Vario 18 c/i AC/DC2023-08-15 Powered suction pump
07612367077989 - Invia Integrated Dressing 2023-07-28 Invia Integrated Dressing - Small (10 X 10)
07612367078023 - Invia Integrated Dressing 2023-07-28 Invia Integrated Dressing – Medium (10 X 15)
07612367078030 - Invia Integrated Dressing 2023-07-28 Invia Integrated Dressing - Large (10 X 25)

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.