FDA.reportPublic FDA data

Sarns™ Modular Perfusion System 8000

Primary DI
00886799000199
Brand
Sarns™ Modular Perfusion System 8000
Company
Terumo Cardiovascular Systems Corporation
Model
16404
Catalog number
16404
Device description
8000 Perfusion System Safety Monitor Providing Air Bubble and Fluid Level Detection Display.
Published
2015-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
DTWMonitor And/Or Control, Level Sensing, Cardiopulmonary Bypass
KRLDetector, Bubble, Cardiopulmonary Bypass

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DTWMonitor And/Or Control, Level Sensing, Cardiopulmonary BypassCardiovascular2
KRLDetector, Bubble, Cardiopulmonary BypassCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K915183000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K915183000SARNS 8000 MODULAR PERFUSION SYSTEM3M Health Care, Sarns1992-07-08DTQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00886799000199PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00886799000199008867990001998867990001990886799000199

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
177655466
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00699753537460Cardiovascular Procedure KitCX-DB080-012026-06-02
00699753537477Cardiovascular Procedure Kit787792026-06-02
00699753532731Cardiovascular Procedure Kit75959-022024-08-23
00699753532663Cardiovascular Procedure Kit73346-022024-08-20
00699753532250Cardiovascular Procedure Kit75197-012024-07-19
00699753531666Cardiovascular Procedure Kit74100-032024-06-04
00699753531345Cardiovascular Procedure Kit77087-012024-05-09
00699753531017Cardiovascular Procedure Kit65167-072024-03-21
00699753537439Cardiovascular Procedure KitCX-SV1272026-05-15
00699753537446Cardiovascular Procedure KitCX-SV1292026-05-15
00699753537453Cardiovascular Procedure Kit787752026-05-15
00812763011007OPUSWAVE01000-002026-05-13
00699753537378Cardiovascular Procedure KitCX-CZ2172026-05-05
00699753537361Cardiovascular Procedure KitCX-GE468X2026-05-04
00699753537385Cardiovascular Procedure KitCX-IS1272026-05-04
00699753537392Cardiovascular Procedure KitCX-SV1262026-05-04
00699753537408Cardiovascular Procedure KitCX-SV1282026-05-04
00699753537415Cardiovascular Procedure Kit780832026-05-04
00699753537422Cardiovascular Procedure Kit786492026-05-04
00699753532601Cardiovascular Procedure Kit74121-032024-08-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850000067134Anivia SG1000 Pump ConsoleAPMTD, Inc.DTW2024-09-11
30695085000529Level 1ICU MEDICAL, INC.DTW2016-10-14
30695085000536Level 1ICU MEDICAL, INC.DTW2016-10-14
30695085000543Level 1ICU MEDICAL, INC.DTW2016-10-14
20695085000522Level 1SMITHS MEDICAL MD, INC.DTW2016-10-14
20695085000539Level 1SMITHS MEDICAL MD, INC.DTW2016-10-14
10695085000549Level 1SMITHS MEDICAL MD, INC.DTW2016-10-14
00886799000212Sarns™ Modular Perfusion System 8000Terumo Cardiovascular Systems CorporationDTW2016-09-23
00886799000212Sarns™ Modular Perfusion System 8000Terumo Cardiovascular Systems CorporationKRL2016-09-23
00886799000229Sarns™ Modular Perfusion System 8000Terumo Cardiovascular Systems CorporationDTW2016-09-23
00886799000229Sarns™ Modular Perfusion System 8000Terumo Cardiovascular Systems CorporationKRL2016-09-23
00886799000236Sarns™ Modular Perfusion System 8000Terumo Cardiovascular Systems CorporationDTW2016-09-23
00886799000236Sarns™ Modular Perfusion System 8000Terumo Cardiovascular Systems CorporationKRL2016-09-23
00886799000342Sarns™ Modular Perfusion System 8000Terumo Cardiovascular Systems CorporationKRL2016-09-23
00886799000342Sarns™ Modular Perfusion System 8000Terumo Cardiovascular Systems CorporationDTW2016-09-23
00886799001721Sarns™ Modular Perfusion System 8000Terumo Cardiovascular Systems CorporationKRL2016-09-23
00886799001721Sarns™ Modular Perfusion System 8000Terumo Cardiovascular Systems CorporationDTW2016-09-23
04987350705693CAPIOXTERUMO CORPORATIONKRL2016-09-09
04987350705730CAPIOXTERUMO CORPORATIONKRL2016-09-09
54987350705698CAPIOXTERUMO CORPORATIONKRL2016-09-09
54987350705735CAPIOXTERUMO CORPORATIONKRL2016-09-09