70105.2786

GUDID 04037691741130

Maquet Cardiopulmonary AG

Cardiopulmonary bypass system blood tubing set
Primary Device ID04037691741130
NIH Device Record Key22637bd1-6049-4faa-8185-8e51e0e13490
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberHIT Set Advanced 7.0, Adult, SOFTLINE Coating
Catalog Number70105.2786
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
Phone+49072229320
Emailinfo.cp@maquet.com
Phone+49072229320
Emailinfo.cp@maquet.com
Phone+49072229320
Emailinfo.cp@maquet.com
Phone+49072229320
Emailinfo.cp@maquet.com
Phone+49072229320
Emailinfo.cp@maquet.com
Phone+49072229320
Emailinfo.cp@maquet.com
Phone+49072229320
Emailinfo.cp@maquet.com
Phone+49072229320
Emailinfo.cp@maquet.com
Phone+49072229320
Emailinfo.cp@maquet.com
Phone+49072229320
Emailinfo.cp@maquet.com
Phone+49072229320
Emailinfo.cp@maquet.com
Phone+49072229320
Emailinfo.cp@maquet.com
Phone+49072229320
Emailinfo.cp@maquet.com
Phone+49072229320
Emailinfo.cp@maquet.com
Phone+49072229320
Emailinfo.cp@maquet.com
Phone+49072229320
Emailinfo.cp@maquet.com
Phone+49072229320
Emailinfo.cp@maquet.com
Phone+49072229320
Emailinfo.cp@maquet.com
Phone+49072229320
Emailinfo.cp@maquet.com
Phone+49072229320
Emailinfo.cp@maquet.com
Phone+49072229320
Emailinfo.cp@maquet.com
Phone+49072229320
Emailinfo.cp@maquet.com
Phone+49072229320
Emailinfo.cp@maquet.com
Phone+49072229320
Emailinfo.cp@maquet.com

Device Dimensions

Total Volume600 Milliliter
Device Size Text, specify0
Total Volume600 Milliliter
Device Size Text, specify0
Total Volume600 Milliliter
Device Size Text, specify0
Total Volume600 Milliliter
Device Size Text, specify0
Total Volume600 Milliliter
Device Size Text, specify0
Total Volume600 Milliliter
Device Size Text, specify0
Total Volume600 Milliliter
Device Size Text, specify0
Total Volume600 Milliliter
Device Size Text, specify0
Total Volume600 Milliliter
Device Size Text, specify0
Total Volume600 Milliliter
Device Size Text, specify0
Total Volume600 Milliliter
Device Size Text, specify0
Total Volume600 Milliliter
Device Size Text, specify0
Total Volume600 Milliliter
Device Size Text, specify0
Total Volume600 Milliliter
Device Size Text, specify0
Total Volume600 Milliliter
Device Size Text, specify0
Total Volume600 Milliliter
Device Size Text, specify0
Total Volume600 Milliliter
Device Size Text, specify0
Total Volume600 Milliliter
Device Size Text, specify0
Total Volume600 Milliliter
Device Size Text, specify0
Total Volume600 Milliliter
Device Size Text, specify0
Total Volume600 Milliliter
Device Size Text, specify0
Total Volume600 Milliliter
Device Size Text, specify0
Total Volume600 Milliliter
Device Size Text, specify0
Total Volume600 Milliliter
Device Size Text, specify0
Total Volume600 Milliliter
Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS104037691741130 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DTRHEAT-EXCHANGER, CARDIOPULMONARY BYPASS

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2022-12-08
Device Publish Date2015-11-12

Devices Manufactured by Maquet Cardiopulmonary AG

04037691002583 - NA2024-09-30
04037691349190 - BMU 402024-09-30
04037691349206 - BMU 402024-09-30
04037691349213 - BMU 402024-09-30
04037691349220 - BMU 402024-09-30
04037691349237 - BMU 402024-09-30
04037691349244 - BMU 402024-09-30
04037691456584 - NA2024-09-30 Wall holder for ambulance. Mandatory for ambulance transportation.

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