ASCENDA®

Basic Information

• Brand Name: ASCENDA®
• Primary DI: 00763000051143
• Version / Model: 8784
• Company Name: MEDTRONIC, INC.
• Labeler DUNS: 796986144
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-08-11
• Public Version: 2
• Public Version Date: 2019-08-09
• Public Version Status: Update
• Public Device Record Key: 3693ede8-7e56-4da5-98c9-b393ee5c62fe

Device Description

CATHETER 8784 ASCENDA PUMP SEG REV KIT

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: Yes
• 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: Yes
• Has Lot/Batch Number: No
• 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
LKK	PUMP, INFUSION, IMPLANTED, PROGRAMMABLE	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
61797	Lumbar cerebrospinal fluid drainage catheterization kit	A collection of sterile devices intended for short-term percutaneous access to the subarachnoid (intrathecal) or epidural space of the lumbar spinal column to drain cerebrospinal fluid (CSF), and/or other fluids of similar physical characteristics, as a means of reducing CSF volume and intracranial pressure (ICP). It includes a spinal infusion/drainage catheter and devices intended for catheter insertion (e.g. Tuohy needle, suture, guidewire) and CSF collection (e.g., drip chamber, drainage bag, tubing set, filter). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00763000051143	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
P860004	294

Device Sizes

Type	Value	Unit	Text
Length	73.7	Centimeter

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -34 – 57 Degrees Celsius
• Type: Storage Environment Temperature
• Temperature Range: -30 – 135 Degrees Fahrenheit