Delta®

GUDID 00643169466425

SHUNT 25131-5 INTL ONLY DELTA SM 1.5

MEDTRONIC PS MEDICAL, INC.

Ventriculo-peritoneal/atrial shunt Ventriculo-peritoneal/atrial shunt Ventriculo-peritoneal/atrial shunt Ventriculo-peritoneal/atrial shunt Ventriculo-peritoneal/atrial shunt Ventriculo-peritoneal/atrial shunt Ventriculo-peritoneal/atrial shunt Ventriculo-peritoneal/atrial shunt Ventriculo-peritoneal/atrial shunt Ventriculo-peritoneal/atrial shunt Ventriculo-peritoneal/atrial shunt Ventriculo-peritoneal/atrial shunt Ventriculo-peritoneal/atrial shunt Ventriculo-peritoneal/atrial shunt Ventriculo-peritoneal/atrial shunt Ventriculo-peritoneal/atrial shunt

• Primary Device ID: 00643169466425
• NIH Device Record Key: 0d8b9610-a8ac-4625-ae6b-35c2c26244cc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Delta®
• Version Model Number: 25131-5
• 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

• Outer Diameter: 2.5 Millimeter
• Outer Diameter: 2.5 Millimeter
• Outer Diameter: 2.5 Millimeter
• Outer Diameter: 2.5 Millimeter
• Outer Diameter: 2.5 Millimeter
• Outer Diameter: 2.5 Millimeter
• Length: 90 Centimeter
• Device Size Text, specify: 0
• Outer Diameter: 2.5 Millimeter
• Length: 90 Centimeter
• Device Size Text, specify: 0
• Outer Diameter: 2.5 Millimeter
• Length: 90 Centimeter
• Device Size Text, specify: 0
• Outer Diameter: 2.5 Millimeter
• Length: 90 Centimeter
• Device Size Text, specify: 0
• Outer Diameter: 2.5 Millimeter
• Length: 90 Centimeter
• Device Size Text, specify: 0
• Outer Diameter: 2.5 Millimeter
• Length: 90 Centimeter
• Device Size Text, specify: 0
• Outer Diameter: 2.5 Millimeter
• Length: 90 Centimeter
• Device Size Text, specify: 0
• Outer Diameter: 2.5 Millimeter
• Length: 90 Centimeter
• Device Size Text, specify: 0
• Outer Diameter: 2.5 Millimeter
• Length: 90 Centimeter
• Device Size Text, specify: 0
• Outer Diameter: 2.5 Millimeter
• Length: 90 Centimeter
• Device Size Text, specify: 0
• Outer Diameter: 2.5 Millimeter
• Length: 90 Centimeter
• Device Size Text, specify: 0
• Outer Diameter: 2.5 Millimeter
• Length: 90 Centimeter
• Device Size Text, specify: 0
• Outer Diameter: 2.5 Millimeter
• Length: 90 Centimeter
• Device Size Text, specify: 0
• Outer Diameter: 2.5 Millimeter
• Length: 90 Centimeter
• Device Size Text, specify: 0
• Outer Diameter: 2.5 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169466425 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K042465

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: 2015-06-24

On-Brand Devices [Delta®]

• 00613994908421: SHUNT 24028-2 DELTA ASY REG SNAP PER 2.0
• 00613994908407: SHUNT 24028-5 DELTA ASY REG SNAP PER 1.5
• 00613994908377: ASSY 24039-5 DELTA REG NO PASSERS
• 00613994908346: CHAMBER 24053 DELTA
• 00613994908230: SHUNT 24028-1 DELTA ASY REG SNAP PER 1.0
• 00613994908100: SHUNT 24012-5 DELTA UNITIZED SML
• 00613994908094: SHUNT 24013-1 DELTA UNITIZED REG 1
• 00613994908087: SHUNT 24013-2 DELTA UNITIZED REG II
• 00613994908070: SHUNT 24013-5 DELTA UNITIZED RGL
• 00613994908063: ASSY 24027-1 DELTA SHUNT SNAP SML 1
• 00613994908049: ASSY 24027-5 DELTA SHUNT SNAP SML 1.5
• 00613994803788: VALVE 42824 DELTA REG PRESS LEVEL II IMP
• 00613994803740: DELTA 25131-1 INTL ONLY SHUNT SM 1.0
• 00613994803733: SHUNT 25131-2 INTL ONLY DELTA SM 2.0
• 00613994803719: SHUNT 25131-5 INTL ONLY DELTA SM 1.5
• 00613994803702: SHUNT 25132-1 INTL ONLY DELTA REG.1.0
• 00613994803696: SHUNT 25132-2 INTL ONLY DELTA REG.2.0
• 00613994803672: SHUNT 25132-5 INTL ONLY DELTA REG 1.5
• 00643169073784: VALVE 42812 DELTA SMALL LEVEL I
• 00643169073753: VALVE 42830 DELTA BURR HOLE 12MM LEV 0.5
• 00643169073746: VALVE 42832 DELTA BURR HOLE 12MM LEVEL 1
• 00643169073722: VALVE 42834 DELTA BURR HOLE 12MM LEVEL 2
• 00643169073715: VALVE 42840 DELTA BURR HOLE 16MM LEV 0.5
• 00643169073685: VALVE 42844 DELTA BURR HOLE 16MM LEVEL 2
• 00643169073524: ASSY 46814 DELTA SHUNT SMALL P/L 2
• 00643169073500: ASSY 46823 DELTA SHUNT REG LEV 1.5
• 00643169073494: ASSY 46824 DELTA SHUNT REG P/L 2
• 00613994965851: SHUNT 25014-1 UNIT DELTA SML PERIT 90
• 00613994965844: SHUNT 25014-2 UNIT DELTA SML PERIT 90
• 00613994965837: SHUNT 25014-5 UNI DELTA SML
• 00613994965783: ASSY 25121-5 DELTA SML SNAP P-CATH 120
• 00613994965714: SHUNT 27499-1 DELTA REG SNAP 2 DSTC
• 00613994965707: SHUNT 27499-5 DELTA REG SNAP 2 DSTC
• 00613994965615: ASSY 27224-5 DELTA NEONATE SNAP 110CM
• 00613994965530: VALVE 27219-1 NEONATE DELTA
• 00613994965523: VALVE 27219-2 NEONATE DELTA
• 00613994965509: VALVE 27219-5 DELTA NEONATE 1.5 IMP
• 00643169507432: SHUNT 27499-1 DELTA REG SNAP 2 DSTC
• 00643169507395: VALVE 27219-5 DELTA NEONATE 1.5 IMP
• 00643169507388: VALVE 27219-1 NEONATE DELTA
• 00643169498419: VALVE 24147 DELTA SML PL 0.5
• 00643169498235: VALVE 24048 DELTA RGL PL 0.5
• 00643169497597: SHUNT 24039-1 DELTA REG PL 1.0 90CM
• 00643169497580: SHUNT 24039-2 DELTA REG PL 2.0 90CM
• 00643169497573: ASSY 24039-5 DELTA REG NO PASSERS
• 00643169497481: ASSY 25121-1 DELTA SML SNAP PERIT 120
• 00643169497474: ASSY 26026-5 DELTA NEONATE 90 CM CATH
• 00643169497429: SHUNT 276081 UNI DSM VCATH23CM PCTH120CM
• 00643169497177: ASSY 24027-1 DELTA SHUNT SNAP SML 1
• 00643169497160: SHUNT 24028-1 DELTA ASY REG SNAP PER 1.0