CPS™

Basic Information

• Brand Name: CPS™
• Primary DI: 05414734508889
• Version / Model: 4F SLITTER
• Catalog Number: DS2A000
• Company Name: ST. JUDE MEDICAL, INC.
• Labeler DUNS: 149818952
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-03-30
• Public Version: 3
• Public Version Date: 2020-05-19
• Public Version Status: Update
• Public Device Record Key: b039918e-d0a1-4844-9a65-ef9453967b57

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: Yes
• 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
DQY	CATHETER, PERCUTANEOUS	Cardiovascular	870.1250	2

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	05414734508889	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Catheter Gauge	4	French

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: 23 – 122 Degrees Fahrenheit
• Type: Handling Environment Temperature
• Temperature Range: -5 – 50 Degrees Celsius
• Type: Storage Environment Temperature
• Temperature Range: -5 – 50 Degrees Celsius
• Type: Storage Environment Temperature
• Temperature Range: 23 – 122 Degrees Fahrenheit
• Type: Special Storage Condition, Specify
• Special Conditions: Store in a cool, dark dry place. Away from sunlight.