BEUDAMED

FDA UDI In Commercial Distribution 🇺🇸 United States

Ascenda®

DI: 00643169359154 · Model: 8781 · MEDTRONIC, INC.

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Product Codes

1

GMDN Terms

1

Identifiers

1

Pkg Device Count

1

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Basic Information

Brand Name: Ascenda®
Primary DI: 00643169359154
Version / Model: 8781
Company Name: MEDTRONIC, INC.
Labeler DUNS: 006261481
Distribution Status: In Commercial Distribution
Device Count in Pkg: 1
Record Status: Published
Publish Date: 2017-09-08
Public Version: 6
Public Version Date: 2025-12-16
Public Version Status: Update
Public Device Record Key: 25f30168-bbf6-4bec-9fc2-3f2a18ee3a50

Device Description

CATH 8781 INTRTHCL KIT LNG OLD CATH eMAN

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) 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	00643169359154	GS1

Customer Contacts

Phone: +1(800)633-8766
Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
P860004	250

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			73.7 cm Pump Segment Length
Device Size Text, specify			66.0 cm Spinal Segment Length

Storage Conditions

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