FDA.reportPublic FDA data

TMC 25

Primary DI
00681490009812
Brand
TMC 25
Company
MEDTRONIC, INC.
Model
TMC25
Device description
CONN TMC25 BIOTREND 1/4 CUVETTE 12PK
Published
2016-06-17
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
20681490009816PackageGS112In Commercial Distribution
00681490009812PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2068149000981620681490009816
00681490009812006814900098126814900098120681490009812

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
20763000946979DLP®872202024-08-15
00199150078455NA11N40R12026-04-26
20643169454594DLP®303172016-09-09
00199150083077NA12V42R2026-05-30
00199150083121NABB1119R72026-05-30
00199150083381NABB12M28R122026-05-30
00199150083442NABB5G97R132026-05-30
00199150083534NABB10U10R172026-05-30
00199150083718NABB6Z03R102026-05-30
00199150083763NA7J79R92026-05-30
00199150083794NABB8P50R62026-05-30
00199150083800NABB12E50R62026-05-30
00199150083817NABB10Z66R152026-05-30
00199150083893NA7E60R32026-05-30
00199150083985NABB12V61R12026-05-30
00199309002416N/ATH91DBS2026-05-29
00613994964120Sones™ Brachial9907072016-06-05
00613994964748Goodale-Lubin™0074602016-06-05
00199150006038N/ATM91D02026-05-23
00199150080649NABB12S94R52026-05-23

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
00886799002032CDI OneView™ Monitoring System Terumo Cardiovascular Systems CorporationDRY2024-07-23
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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04037691447445BMU 40Maquet Cardiopulmonary AGDRY2021-09-30