FDA.reportPublic FDA data

NA

Primary DI
00681490009836
Brand
NA
Company
MEDTRONIC, INC.
Model
TMC50
Device description
CONN TMC50 BIOTREND 1/2 CUVETTE 12PK
Published
2016-06-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DRYMONITOR, BLOOD-GAS, ON-LINE, CARDIOPULMONARY BYPASS

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DRYMonitor, Blood-Gas, On-Line, Cardiopulmonary BypassCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K012743000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K012743000TRILLIUM TRI-OPTIC MEASUREMENT CELL, MODEL TMC 25T, TMC38 T, TMC 50TMedtronic Perfusion Systems2001-09-14DRY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20681490009830PackageGS112In Commercial Distribution
00681490009836PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2068149000983020681490009830
00681490009836006814900098366814900098360681490009836

GMDN Terms#

Term, Definition table
TermDefinition
Cardiopulmonary bypass system blood gas sensorA sterile transducer used with a cardiopulmonary bypass system to detect and measure the partial pressure of gases in the blood being circulated by the system. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-8766Corporate.UDI@medtronic.com

Regulatory Flags#

DUNS number
006261481
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00199309001242Percept™ PC BrainSense™B352002026-08-07
00199309001259Percept™ RCB353002026-08-07
00824846005445NA12T76R12026-07-30
00824846005469NABB2Q31R112026-07-30
00824846005667NABB9R33R162026-07-30
00824846006022NABB12S36R2026-07-30
00824846007944NABB12W03R12026-07-30
00613994746627ATTAIN SELECT™ II624890D022016-07-16
00763000862336MyCareLink™249552026-07-26
00763000060374LINQ II™LNQ222020-07-18
00763000422615SYNCHROMED®II8637-402021-04-11
00763000634094SYNCHROMED® II8637-202022-08-11
00763000634100SYNCHROMED® II8637-402022-08-11
00643169508149SYNCHROMED® II8637-202016-04-27
00643169508156SYNCHROMED® II8637-402016-04-27
00643169630505SYNCHROMED® II8637-202018-08-17
00643169630512SYNCHROMED® II8637-402018-08-17
00643169100824SYNCHROMED ® II8637-402016-04-27
00643169100831SYNCHROMED ® II8637-202016-04-27
00199150084036MiniMed Flex Starter KitMMT-8076B2026-07-19

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00886799001943CDI OneView™ Monitoring System Terumo Cardiovascular Systems CorporationDRY2024-07-23
00886799001950CDI OneView™ Monitoring System Terumo Cardiovascular Systems CorporationDRY2024-07-23
00886799001967CDI OneView™ Monitoring System Terumo Cardiovascular Systems CorporationDRY2024-07-23
00886799001974CDI OneView™ Monitoring System Terumo Cardiovascular Systems CorporationDRY2024-07-23
00886799001981CDI OneView™ Monitoring System Terumo Cardiovascular Systems CorporationDRY2024-07-23
00886799001998CDI OneView™ Monitoring System Terumo Cardiovascular Systems CorporationDRY2024-07-23
00886799002001CDI OneView™ Monitoring System Terumo Cardiovascular Systems CorporationDRY2024-07-23
00886799002018CDI OneView™ Monitoring System Terumo Cardiovascular Systems CorporationDRY2024-07-23
00886799002025CDI OneView™ Monitoring System Terumo Cardiovascular Systems CorporationDRY2024-07-23
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00886799002049CDI OneView™ Monitoring System Terumo Cardiovascular Systems CorporationDRY2024-07-23
10886799001865CDI OneView™ Monitoring System Terumo Cardiovascular Systems CorporationDRY2024-07-23
10886799001872CDI OneView™ Monitoring System Terumo Cardiovascular Systems CorporationDRY2024-07-23
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05060434422521QuantumSPECTRUM MEDICAL LIMITEDDRY2023-04-10
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05060434423306QuantumSPECTRUM MEDICAL LIMITEDDRY2022-10-17
05060434422293QuantumSPECTRUM MEDICAL LIMITEDDRY2022-01-12
04037691447445BMU 40Maquet Cardiopulmonary AGDRY2021-09-30