Ascenda®

GUDID 00643169561601

ACCY 8785 KIT ASCENDA ADT LOW PTFE SYMBL

MEDTRONIC, INC.

Lumbar cerebrospinal fluid drainage catheterization kit

• Primary Device ID: 00643169561601
• NIH Device Record Key: 9605d51c-d71b-40a5-92cc-7fdb82121644
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ascenda®
• Version Model Number: 8785
• Company DUNS: 796986144
• Company Name: MEDTRONIC, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: true
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -34 Degrees Celsius and 57 Degrees Celsius
• Storage Environment Temperature: Between -34 Degrees Celsius and 57 Degrees Celsius
• Storage Environment Temperature: Between -34 Degrees Celsius and 57 Degrees Celsius
• Storage Environment Temperature: Between -34 Degrees Celsius and 57 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169561601 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P860004

FDA Product Code

• LKK: PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-08-09
• Device Publish Date: 2017-09-04

On-Brand Devices [Ascenda®]

• 00643169783034: CATH 8782 ASCENDA SPINL REVKIT LONG EMAN
• 00643169783027: CATH 8780 ASCENDA SPINAL SGMNT LONG EMAN
• 00643169561601: ACCY 8785 KIT ASCENDA ADT LOW PTFE SYMBL
• 00643169359178: CATH 8784 PROXIMAL REV KIT OLD CATH eMAN
• 00643169359154: CATH 8781 INTRTHCL KIT LNG OLD CATH eMAN
• 00763000051150: ACCY 8785 ASCENDA ANCHOR DEPLOY TOOL
• 00763000051143: CATHETER 8784 ASCENDA PUMP SEG REV KIT
• 00763000051136: CATHETER 8782 ASCENDA SPINAL REV KIT
• 00763000051129: CATHETER 8781 ASCENDA INTRATHECAL 66CM
• 00763000051112: CATHETER 8780 ASCENDA INTRATHECAL 86CM
• 00763000852634: ACCY 8785 ASCENDA ANCHOR DEPLOY TOOL
• 00763000852627: CATH 8784 ASCENDA PUMP SEG REV KIT EMAN
• 00763000852610: CATH 8782 ASCENDA SPINAL REV KIT EMAN
• 00763000852603: CATH 8781 ASCENDA INTRATHECAL 66CM EMAN
• 00763000852597: CATH 8780 ASCENDA INTRATHECAL 86CM EMAN
• 00763000916671: CATH 8784 ASCENDA PUMP SEG REV KIT EMAN
• 00763000916664: CATH 8781 ASCENDA INTRATHECAL 66CM EMAN
• 00763000916657: CATH 8780 ASCENDA INTRATHECAL 86CM EMAN