TMC 38

GUDID 20681490009823

CONN TMC38 BIOTREND 3/8 CUVETTE 12PK

MEDTRONIC, INC.

Cardiopulmonary bypass system blood gas sensor
Primary Device ID20681490009823
NIH Device Record Key3ced3cbe-b81b-4fde-a931-f3a158c4ab1b
Commercial Distribution StatusIn Commercial Distribution
Brand NameTMC 38
Version Model NumberTMC38
Company DUNS006261481
Company NameMEDTRONIC, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS100681490009829 [Primary]
GS120681490009823 [Package]
Contains: 00681490009829
Package: PK [12 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DRYMONITOR, BLOOD-GAS, ON-LINE, CARDIOPULMONARY BYPASS

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-06-17

Devices Manufactured by MEDTRONIC, INC.

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00199150050871 - NA2025-09-29 CUSTOM PACK BB11R66R2 TBL 1/4
00763000877033 - SPRINTER® LEGEND2025-09-29 BALLOON SPL15006X SPR LEG RX US M
00763000877040 - SPRINTER® LEGEND2025-09-29 BALLOON SPL15010X SPR LEG RX US M
00763000877057 - SPRINTER® LEGEND2025-09-29 BALLOON SPL15012X SPR LEG RX US M

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