BEUDAMED

FDA UDI Not in Commercial Distribution 🇺🇸 United States

Select 3D™ II

DI: 00643169696266 · Model: CB78422 · MEDTRONIC, INC.

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Product Codes

1

GMDN Terms

1

Identifiers

1

Pkg Device Count

1

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Basic Information

Brand Name: Select 3D™ II
Primary DI: 00643169696266
Version / Model: CB78422
Company Name: MEDTRONIC, INC.
Labeler DUNS: 006261481
Distribution Status: Not in Commercial Distribution
Device Count in Pkg: 1
Record Status: Published
Publish Date: 2017-03-04
Public Version: 6
Public Version Date: 2024-06-19
Public Version Status: Update
Public Device Record Key: ecd449ea-ca73-4963-961b-34d08208b3ef
Distribution End Date: 2018-10-05

Device Description

CANNULA CB78422 SELECT 3DII 22FR

Device Characteristics

Single Use: Yes
Prescription Use (Rx): No
Over the Counter (OTC): No
Kit: No
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
DWF	CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS	Cardiovascular	870.4210	2

GMDN Terms

Code	Name	Definition	Implantable	Status
34893	Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, return	A semi-rigid or rigid tube intended to be surgically inserted into an artery or vein to serve as a channel for the extracorporeal transport of oxygenated blood to a patient during cardiopulmonary bypass and/or extracorporeal membrane oxygenation; in some settings it may be referred to as an arterial cannula. It is typically inserted using a compatible trocar blade which may be included. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00643169696266	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K061254	000

Device Sizes

Type	Value	Unit	Text
Catheter Gauge	22.0	French

Storage Conditions

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