J&J DePuy Synthes convenience kit 101043438

GUDID 07612367080590

Convenience kit containing: 1 x Dominant Flex Rack (item # 071.0003 ) with U.S. power cord 1 pack of Coupling Piece 90° (item # 077.1019, 10 pieces) 1 x IFU of each language region (EU 1, EU 2, Japan, Korea, China)

Medela AG

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 Surgical suction pump Surgical suction pump Surgical suction pump
Primary Device ID07612367080590
NIH Device Record Keyffaee3b1-037e-45c4-8d64-6d0d40e280e2
Commercial Distribution StatusIn Commercial Distribution
Brand NameJ&J DePuy Synthes convenience kit
Version Model Number101043438
Catalog Number101043438
Company DUNS488293218
Company NameMedela AG
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
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+1-877-735-1626
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
Phone+1-877-735-1626
Emailinfo-healthcare@medela.com
Phone+1-877-735-1626
Emailinfo-healthcare@medela.com

Device Identifiers

Device Issuing AgencyDevice ID
GS107612367080590 [Primary]

FDA Product Code

BTAPump, Portable, Aspiration (Manual Or Powered)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-12-09
Device Publish Date2021-12-01

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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