CPS™

Basic Information

• Brand Name: CPS™
• Primary DI: 05415067046178
• Version / Model: DS2A006
• Catalog Number: DS2A006
• Company Name: ST. JUDE MEDICAL, INC.
• Labeler DUNS: 149818952
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-11-02
• Public Version: 1
• Public Version Date: 2022-11-10
• Public Version Status: New
• Public Device Record Key: 122d5235-319a-4d60-97e6-d729d297f65f

Device Description

Universal II Slitter

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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DWS	INSTRUMENTS, SURGICAL, CARDIOVASCULAR	Cardiovascular	870.4500	1

GMDN Terms

Code	Name	Definition	Implantable	Status
45608	Intravascular catheter slitter	A hand-held, surgical instrument used to facilitate the removal of an intravascularly placed catheter, typically a guide catheter used to introduce a variety of transvenous devices [e.g., a balloon catheter, oxygen (O2) and/or other sensors, pacing electrode/leads]. It has a specially shielded steel blade that is integrated into the handle. The exposed end of the transvenous device is typically placed and held in a protective channel of this device (the slitter) and the physician pulls the proximal end of the catheter against the blade in a smooth, firm, motion; this splits open the catheter hub and the tubing wall, leaving the transvenous device intact, in situ. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05415067046178	GS1

Customer Contacts

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

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Excursions permitted: -20°-50°C, -4°-122°F
• Type: Handling Environment Humidity
• Temperature Range: 10 – 90 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: Low: 68 Degrees Fahrenheit
• Type: Storage Environment Humidity
• Temperature Range: 10 – 90 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: Low: 20 Degrees Celsius