NA

Basic Information

• Brand Name: NA
• Primary DI: 00643169950146
• Version / Model: 203CX
• Company Name: MEDTRONIC, INC.
• Labeler DUNS: 006261481
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-04-02
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 3089ee82-678d-4711-a5ee-0c0a88a39b98

Device Description

CABLE 203CX COAXIAL UMBILICAL ROHS

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
Primary	00643169950146	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
P020045	080

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Keep dry
• Type: Special Storage Condition, Specify
• Special Conditions: Fragile: handle with care
• Type: Handling Environment Temperature
• Temperature Range: -35 – 58 Degrees Celsius
• Type: Handling Environment Humidity
• Temperature Range: – 85 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: 15 – 30 Degrees Celsius
• Type: Storage Environment Humidity
• Temperature Range: – 85 Percent (%) Relative Humidity