HLS Set 701069078

GUDID 04058863080383

HLS Set Advanced 7.0, Adult, BIOLINE Coating

Maquet Cardiopulmonary AG

Cardiopulmonary bypass system tubing set
Primary Device ID04058863080383
NIH Device Record Key5e001841-a422-4a15-8f1f-bb6b0735a37d
Commercial Distribution StatusIn Commercial Distribution
Brand NameHLS Set
Version Model NumberBEQ-HLS 7050 USA
Catalog Number701069078
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 Producttrue
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

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

Device Identifiers

Device Issuing AgencyDevice ID
GS104058863080383 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DTZOxygenator, Cardiopulmonary Bypass

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-08-06
Device Publish Date2021-07-29

On-Brand Devices [HLS Set]

04058863080383HLS Set Advanced 7.0, Adult, BIOLINE Coating
04058863078861HIT Set Advanced 7.0, Adult, SOFTLINE Coating
04058863076355HLS Set Advanced 5.0, Small Adult, BIOLINE Coating
04037691588285HKH 8870 Holder for priming bag

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