BioGlide®

GUDID 00763000027988

CATH 96118 BIOGLIDE EDM VENT 35 CM

MEDTRONIC PS MEDICAL, INC.

Intracerebral infusion/drainage catheter, short-term

• Primary Device ID: 00763000027988
• NIH Device Record Key: a18fc6ca-f879-46cf-870a-3c0ef85ea40f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BioGlide®
• Version Model Number: 96118
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	00763000027988 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K000641

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-03-30
• Device Publish Date: 2020-03-20

On-Brand Devices [BioGlide®]

• 00613994800725: CATHETER 93522 BIOGLIDE PERITONEAL
• 00613994800718: CATH 91503 BIOGLIDE VENT 23CM CLOSED IMP
• 00643169010222: VALVE 92316 CSF CONT SML HIGH BIO
• 00643169010215: VALVE 92322 CSF CONT REG LOW BIO
• 00643169010208: VALVE 92324 CSF CONT REG MED BIO
• 00643169010192: VALVE 92326 CSF CONT REG HIGH BIO
• 00643169496965: VALVE 92312 CSF CONTRD SML LOW BIO
• 00643169496958: VALVE 92322 CSF CONT REG LOW BIO
• 00643169483224: VALVE 92316 CSF CONT SML HIGH BIO
• 00643169483217: VALVE 92324 CSF CONT REG MED BIO
• 00643169483200: VALVE 92326 CSF CONT REG HIGH BIO
• 00643169472808: CATHETER 27536 PERIT W/BIOGLIDE 8 SLITS
• 00643169472600: CATH 27726 VENT 8MM HLS NUM LM 23CM BIO
• 00643169472570: CATH 27705 EDM NUM LNGTHMARK BIO 35CM
• 00643169472518: CATH 96115 BIOGLIDE EDM VENT 20 CM
• 00643169466456: CATH 96118 BIOGLIDE EDM VENT 35 CM
• 00643169466289: CATH 91503 BIOGLIDE VENT 23CM CLOSED IMP
• 00643169466272: VALVE 92314 CSF CONT SML MED BIO
• 00643169466005: CATHETER 93522 BIOGLIDE PERITONEAL
• 00673978231716: CATH 96118 BIOGLIDE EDM VENT 35 CM
• 00673978231709: CATH 96115 BIOGLIDE EDM VENT 20 CM
• 00763000027605: CATHETER 93522 BIOGLIDE PERITONEAL
• 00763000030179: VALVE 92322 CSF CONT REG LOW BIO
• 00763000029340: VALVE 92324 CSF CONT REG MED BIO
• 00763000027827: VALVE 92314 CSF CONT SML MED BIO
• 00763000028916: CATHETER 27536 PERIT W/BIOGLIDE 8 SLITS
• 00763000027988: CATH 96118 BIOGLIDE EDM VENT 35 CM
• 00763000027834: CATH 91503 BIOGLIDE VENT 23CM CLOSED IMP
• 00763000028749: CATH 27705 EDM NUM LNGTHMARK BIO 35CM