CPS DIRECT™

Basic Information

• Brand Name: CPS DIRECT™
• Primary DI: 05414734218252
• Version / Model: SLII
• Catalog Number: DS2C007
• Company Name: ST. JUDE MEDICAL, INC.
• Labeler DUNS: 790268031
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-03-19
• Public Version: 5
• Public Version Date: 2019-06-07
• Public Version Status: Update
• Public Device Record Key: d41fca6e-1a46-463a-a184-28dad4c52c2b
• Distribution End Date: 2018-04-05

Device Description

Slittable Outer Guide Catheter

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: MR Unsafe
• 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
58865	Vascular catheter introduction set, nonimplantable	A collection of sterile, nonimplantable, invasive devices intended to provide percutaneous vascular access to enable introduction of a catheter (not included) into the vascular system. It includes a non-steerable introducer sheath with an inner obturator/dilator, and typically an additional access device(s) [e.g., guidewire, introducer needle, syringe, additional dilators] which may include a haemostatic valve to control blood loss, usually to enable arterial access. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05414734218252	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			115-S
Catheter Gauge	9	French

Storage Conditions

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