MAQUET HL20

Primary DI
04037691024110
Brand
MAQUET HL20
Company
Maquet Cardiopulmonary AG
Model
BSC 20-500
Catalog number
70101.0858
Device description
BSC 20-500 Bubble Sensor
Published
2017-01-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
DTQConsole, Heart-Lung Machine, Cardiopulmonary Bypass

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DTQConsole, Heart-Lung Machine, Cardiopulmonary BypassCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K943803000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K943803000JOSTRA HL-20 INTEGRATED PERFUSION SYSTEMJanus Biomedical, Inc.1996-01-30DTQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04037691024110PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04037691024110040376910241104037691024110

GMDN Terms#

Term, Definition table
TermDefinition
Cardiopulmonary bypass system air bubble/fluid level detectorA mains electricity (AC-powered) device designed to detect air bubbles in blood returned to the body from the extracorporeal circuit of a cardiopulmonary (heart-lung) bypass system, and to detect when blood falls below acceptable levels, typically in the venous drip chamber. The device typically consists of an electronic unit and ultrasonic sensors; it usually triggers alarms and activates automated mechanisms to turn off the blood flow when bubbles are detected or an abnormal fluid level occurs. It is typically an integral part of the cardiopulmonary bypass system.

Regulatory Flags#

DUNS number
316153865
Device count
1
Serial number
true
Manufacturing date on label
true

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