70106.6547

GUDID 04058863039725

Maquet Cardiopulmonary AG

Haemoconcentrator
Primary Device ID04058863039725
NIH Device Record Key36302530-29d0-488a-bf25-3c3f313f0bd4
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberBC 140 Plus HEMOCONCENTRATOR
Catalog Number70106.6547
Company DUNS316153865
Company NameMaquet Cardiopulmonary 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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+49072229320
Emailinfo.cp@maquet.com

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS104058863030906 [Package]
Package: [10 Units]
In Commercial Distribution
GS104058863039725 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KDIDialyzer, high permeability with or without sealed dialysate system

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-12-20

Devices Manufactured by Maquet Cardiopulmonary AG

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04037691032528 - NA2023-06-02
04037691576640 - Quadrox-iD 2022-12-13
04037691588285 - HLS Set2022-12-13
04037691741130 - NA2022-12-08
04037691741543 - NA2022-12-08
04037691773513 - NA2022-12-08
04037691009025 - NA2022-12-06

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