Delta®, BioGlide®

GUDID 00643169011069

VALVE 92824 BIOGLIDE DELTA REG. 2.0

MEDTRONIC PS MEDICAL, INC.

Ventriculo-peritoneal/atrial shunt valve

• Primary Device ID: 00643169011069
• NIH Device Record Key: b90e7a2a-f0d7-4241-a74b-af75d3dea192
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Delta®, BioGlide®
• Version Model Number: 92824
• Company DUNS: 089055867
• Company Name: MEDTRONIC PS MEDICAL, 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: false
• 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
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169011069 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K951258

FDA Product Code

• JXG: Shunt, central nervous system and components

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-06-29

On-Brand Devices [Delta®, BioGlide®]

• 00643169011113: VALVE 92812 BIOGLIDE DELTA SM 1.0
• 00643169011106: VALVE 92813 BIOGLIDE DELTA SM 1.5
• 00643169011090: VALVE 92814 BIOGLIDE DELTA SM 2.0
• 00643169011069: VALVE 92824 BIOGLIDE DELTA REG. 2.0
• 00643169011014: SHUNT 96812 DELTA ASSY SMALL P/L 1.0 BIO
• 00643169011007: SHUNT 96813 DELTA ASSY SMALL P/L 1.5 BIO
• 00643169010994: SHUNT 96814 DELTA ASSY SMALL P/L 2.0 BIO
• 00643169010970: SHUNT 96823 DELTA ASSY REG P/L 1.5 BIO
• 00643169010963: SHUNT 96824 DELTA ASSY REG P/L 2.0 BIO
• 00643169483194: SHUNT 96813 DELTA ASSY SMALL P/L 1.5 BIO
• 00643169483187: SHUNT 96814 DELTA ASSY SMALL P/L 2.0 BIO
• 00643169483170: SHUNT 96823 DELTA ASSY REG P/L 1.5 BIO
• 00643169483163: SHUNT 96824 DELTA ASSY REG P/L 2.0 BIO
• 00643169473010: SHUNT 96812 DELTA ASSY SMALL P/L 1.0 BIO
• 00643169473003: SHUNT 96822 DELTA ASSY REG P/L 1.0 BIO
• 00643169472563: SHUNT 27498 DELTA ASSY REG BG 0.5
• 00643169472556: SHUNT 27497 DELTA ASSY SMALL BG 0.5
• 00673978247823: SHUNT 27497 DELTA ASSY SMALL BG 0.5