Tmc 38

FDA UDI

Class II (US FDA UDI)

by Medtronic, Inc.

Identity

Trade Name: TMC 38 FDA UDI
Generic Name: Cardiopulmonary bypass system blood gas sensor FDA UDI
Device Name: CONN TMC38 BIOTREND 3/8 CUVETTE 12PK FDA UDI
Model / Reference: TMC38 FDA UDI
Description: CONN TMC38 BIOTREND 3/8 CUVETTE 12PK FDA UDI

Identifiers

Primary DI / UDI-DI: 00681490009829 FDA UDI
510(k) Number: K012743 FDA UDI
FDA Product Code: DRY FDA UDI
GMDN Term: Cardiopulmonary bypass system blood gas sensor FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.4330 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Cardiopulmonary bypass system blood gas sensor

Tmc 38 by Medtronic, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cardiopulmonary bypass system blood gas sensor.

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DATA MASTER — SORIN GROUP ITALIA SRL · Class II
CDI™ H/S Cuvette 1/4 x 1/4 - Japan — Terumo Cardiovascular Systems Corporation · Class II
B-CAPTA — SORIN GROUP ITALIA SRL · Class II
CDI™ H/S Cuvette 1/2 x 1/2 with Extension — Terumo Cardiovascular Systems Corporation · Class II
B-CAPTA — SORIN GROUP ITALIA SRL · Class II

Cleared under the same submission

K012743 also covers:

TMC 25 — MEDTRONIC, INC.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Medtronic, Inc.

Sources (1)

FDA UDI 3ced3cbe-b81b-4fde-a931-f3a158c4ab1b 36 fields · synced Jun 8, 2026