TMC 38

Basic Information

• Brand Name: TMC 38
• Primary DI: 00681490009829
• Version / Model: TMC38
• Company Name: MEDTRONIC, INC.
• Labeler DUNS: 006261481
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-06-17
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 3ced3cbe-b81b-4fde-a931-f3a158c4ab1b

Device Description

CONN TMC38 BIOTREND 3/8 CUVETTE 12PK

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DRY	MONITOR, BLOOD-GAS, ON-LINE, CARDIOPULMONARY BYPASS	Cardiovascular	870.4330	2

GMDN Terms

Code	Name	Definition	Implantable	Status
31715	Cardiopulmonary bypass system blood gas sensor	A 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20681490009823	GS1	PK	12	In Commercial Distribution
Primary	00681490009829	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K012743	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			0.95 CM Port Outer Diameter