BEUDAMED

FDA UDI Not in Commercial Distribution 🇺🇸 United States

TMC38

DI: 00643169790711 · Model: CB4715R1 · MEDTRONIC, INC.

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Product Codes

1

GMDN Terms

1

Identifiers

2

Pkg Device Count

1

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Basic Information

Brand Name: TMC38
Primary DI: 00643169790711
Version / Model: CB4715R1
Company Name: MEDTRONIC, INC.
Labeler DUNS: 006261481
Distribution Status: Not in Commercial Distribution
Device Count in Pkg: 1
Record Status: Published
Publish Date: 2017-02-02
Public Version: 4
Public Version Date: 2024-11-12
Public Version Status: Update
Public Device Record Key: 8c6e67ad-f73a-4c31-9ae8-8910c9005458
Distribution End Date: 2024-10-21

Device Description

TUBING CB4715R1 10PK CB TMC38 W/6INCH LN

Device Characteristics

Single Use: Yes
Prescription Use (Rx): Yes
Over the Counter (OTC): No
Kit: Yes
Combination Product: Yes
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
35441	Cardiopulmonary bypass system blood tubing set	A collection of sterile devices including tubing and typically clamps, filters, connectors, and stopcocks, used in a circuit for a cardiopulmonary bypass procedure. The tubing is typically polymeric and may be heparin coated. It is typically used in the blood pump head of a cardiopulmonary bypass system. The tubing, when used in a roller type pump, will be cyclically compressed by the blood pump to cause the blood to flow through the heart-lung bypass 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	20643169790722	GS1	PK	10	Not in Commercial Distribution	2024-10-21
Primary	00643169790711	GS1

Customer Contacts

Phone: +1(800)633-8766
Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Length	15.2	Centimeter

Storage Conditions

Type: Storage Environment Temperature
Temperature Range: – 40 Degrees Celsius