BEUDAMED

FDA UDI In Commercial Distribution 🇺🇸 United States

N/A

DI: 00763000412579 · Model: 203CXC · 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: N/A
Primary DI: 00763000412579
Version / Model: 203CXC
Company Name: MEDTRONIC, INC.
Labeler DUNS: 006261481
Distribution Status: In Commercial Distribution
Device Count in Pkg: 1
Record Status: Published
Publish Date: 2023-02-25
Public Version: 1
Public Version Date: 2023-03-06
Public Version Status: New
Public Device Record Key: 33b2ceb6-b9cf-40ce-b183-40fa3e5d7892

Device Description

CABLE 203CXC COAX UMBIL BOX 12 TIJ MDR

Device Characteristics

Single Use: Yes
Prescription Use (Rx): Yes
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
LPB	Cardiac ablation percutaneous catheter	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
56300	Liquid nitrous oxide coaxial tubing	A sterile, double lumen (coaxial) tube in a straight or spiral design used to conduct liquid nitrous oxide (N2O) from an N2O cylinder to a medical device to act as a refrigerant typically for cryotherapy, e.g., cardiac cryoablation. It is typically constructed of polymeric material and may be available in various lengths. The coaxial design (inner and outer tubing) facilitates the removal of the exhaust N2O gases. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20763000412573	GS1	PK	12	In Commercial Distribution
Primary	00763000412579	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
P020045	092

Storage Conditions

Type: Special Storage Condition, Specify
Special Conditions: Keep dry
Type: Handling Environment Humidity
Temperature Range: – 85 Percent (%) Relative Humidity