Natus® NT901162

GUDID 00382830055536

NATUS DP STANDARD VALVE SYSTEM, BROWN (HIGH): 120-170 mmH2O

NATUS MEDICAL INCORPORATED

Ventriculo-peritoneal/atrial shunt

• Primary Device ID: 00382830055536
• NIH Device Record Key: 15f9f2a1-48a8-421f-9fff-c4e666455f92
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Natus®
• Version Model Number: NT901162
• Catalog Number: NT901162
• Company DUNS: 081325959
• Company Name: NATUS MEDICAL INCORPORATED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-800-356-0007
• Email: Madison.Helpdesk@Natus.com
• Phone: 1-800-356-0007
• Email: Madison.Helpdesk@Natus.com
• Phone: 1-800-356-0007
• Email: Madison.Helpdesk@Natus.com
• Phone: 1-800-356-0007
• Email: Madison.Helpdesk@Natus.com
• Phone: 1-800-356-0007
• Email: Madison.Helpdesk@Natus.com
• Phone: 1-800-356-0007
• Email: Madison.Helpdesk@Natus.com
• Phone: 1-800-356-0007
• Email: Madison.Helpdesk@Natus.com
• Phone: 1-800-356-0007
• Email: Madison.Helpdesk@Natus.com
• Phone: 1-800-356-0007
• Email: Madison.Helpdesk@Natus.com
• Phone: 1-800-356-0007
• Email: Madison.Helpdesk@Natus.com
• Phone: 1-800-356-0007
• Email: Madison.Helpdesk@Natus.com
• Phone: 1-800-356-0007
• Email: Madison.Helpdesk@Natus.com
• Phone: 1-800-356-0007
• Email: Madison.Helpdesk@Natus.com
• Phone: 1-800-356-0007
• Email: Madison.Helpdesk@Natus.com
• Phone: 1-800-356-0007
• Email: Madison.Helpdesk@Natus.com
• Phone: 1-800-356-0007
• Email: Madison.Helpdesk@Natus.com
• Phone: 1-800-356-0007
• Email: Madison.Helpdesk@Natus.com
• Phone: 1-800-356-0007
• Email: Madison.Helpdesk@Natus.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 Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00382830055536 [Primary]
GS1	10381780033257 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152897

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: 2020-04-13
• Device Publish Date: 2020-04-03

On-Brand Devices [Natus®]

• 00382830048644: Cranial Access Kit
• 00382830048637: Cranial Access Kit
• 00382830048620: Cranial Access Kit
• 00382830048613: Cranial Access Kit
• 00382830048606: Cranial Access Kit
• 00382830048590: Cranial Access Kit
• 00382830055420: PERITONEAL INTRODUCER SHEATHS, 81 cm
• 00382830055727: Radiopaque Silicone Suturable Tubing Clamps For Natus F8 Catheter
• 00382830055956: Radiopaque Silicone Suturable Tubing Clamps For Natus F5 Catheter
• 00382830056175: Radiopaque Silicone Suturable Tubing Clamps For Natus F7 Catheter
• 00382830055246: Malleable Tunnelers 65 cm
• 00382830055468: Malleable Tunnelers 45 cm
• 00382830056250: Y-LUMBAR CATHETER F5
• 00382830056243: Right Angle Ventricular Catheter F8, 11 cm (Proximal Length: 11 cm - Distal Length: 2 cm)
• 00382830056236: ATRIAL CATHETER F6, 46 cm, RADIOPAQUE (O.D.: 2.1 mm x I.D. 1.1 mm)
• 00382830056229: Finned Ventricular Catheter F8, 15 cm
• 00382830056212: CSF Reservoir Kit (With Right Angle Ventricular Catheter F8, 7 cm)
• 00382830056205: BURR HOLE RESERVOIR AND SILICONE CAP (Polypropylene - Ø 6.4 mm - Depth 2.5 mm)
• 00382830056199: BURR HOLE RESERVOIR AND SILICONE CAP WITH F8 SIDE ARM (Polypropylene - Ø 6.4 mm - Depth 0.8 mm)
• 00382830056182: BURR HOLE RESERVOIR AND SILICONE CAP WITH F8 SIDE ARM (Polypropylene - Ø 6.4 mm - Depth 2.5 mm)
• 00382830056168: BURR HOLE RESERVOIR AND SILICONE CAP (Stainless Steel - Ø 10 mm - Depth 0.8 mm)
• 00382830056151: BURR HOLE RESERVOIR AND SILICONE CAP (Stainless Steel - Ø 6.4 mm - Depth 2.5 mm)
• 00382830056144: Natus DP Pediatric Burr Hole Shunt System, Blue (Very Low): 15-40 mmH2O
• 00382830056137: NATUS DP PEDIATRIC VALVE SYSTEM, BROWN (HIGH): 120-170 mmH2O
• 00382830056120: Contour-Flex Valve System, Small, High Pressure At 20 ml/hr: 12.7-18.0 cm H2O
• 00382830056113: Contour-Flex Valve System, Small, Medium Pressure At 20 ml/hr: 6.7-11.8 cm H2O
• 00382830056106: Contour-Flex Valve System, Small, Low Pressure At 20 ml/hr: 1.2-5.8 cm H2O
• 00382830056090: Contour-Flex Valve System, Regular, High Pressure At 20 ml/hr: 12.7-18.0 cm H2O
• 00382830056083: Contour-Flex Valve System, Regular, Medium Pressure At 20 ml/hr: 6.7-11.8 cm H2O
• 00382830056076: Gravity Compensating Accessory, Low Pressure Range (White)
• 00382830056069: NATUS DP STANDARD VALVE SYSTEM, YELLOW (MEDIUM): 80-120 mmH2O
• 00382830056052: Subcutaneous Tube Passer
• 00382830056045: Contour-Flex Valve Unit, Small, Medium Pressure At 20 ml/hr: 6.7 - 11.8 cm H2O
• 00382830056038: NATUS DP PEDIATRIC VALVE SYSTEM, YELLOW (MEDIUM): 80-120 mmH2O
• 00382830056021: Radiopaque Polypropylene Plug
• 00382830056014: PERITONEAL CATHETER F6, 110 cm, RADIOPAQUE WITH 16 SLITS (O.D.: 2.1 mm x I.D.: 1.1 mm)
• 00382830056007: Straight Ventricular Catheter F8, 25 cm, With Length Markers
• 00382830055994: Contour-Flex Valve System, Regular, Low Pressure At 20 ml/hr: 1.2-5.8 cm H2O
• 00382830055987: Contour-Flex Valve Unit, Regular, High Pressure At 20 ml/hr: 12.7 - 18.0 cm H2O
• 00382830055970: Right Angle Ventricular Catheter F8, 7 cm (Proximal Length: 7 cm - Distal Length: 2 cm)
• 00382830055963: BURR HOLE RESERVOIR AND SILICONE CAP (Stainless Steel - Ø 10 mm - Depth 2.5 mm)
• 00382830055949: BURR HOLE RESERVOIR AND SILICONE CAP WITH F8 SIDE ARM (Stainless Steel - Ø 10 mm - Depth 0.8 mm
• 00382830055932: NATUS DP STANDARD VALVE SYSTEM, GREEN (VERY HIGH): 170-230 mmH2O
• 00382830055925: Right Angle Ventricular Catheter F8, 9 cm (Proximal Length: 9 cm - Distal Length: 2 cm)
• 00382830055918: NATUS DP STANDARD VALVE UNIT, GREEN (VERY HIGH): 170-230 mmH2O
• 00382830055901: Peritoneal Catheter F7, 91 cm, With Radiopaque Stripe and Length Markers
• 00382830055895: Contour-Flex Valve Unit, Small, Low Pressure At 20 ml/hr: 1.2 - 5.8 cm H2O
• 00382830055888: BURR HOLE RESERVOIR AND SILICONE CAP WITH F8 SIDE ARM (Stainless Steel - Ø 10 mm - Depth 2.5 mm
• 00382830055871: NATUS DP STANDARD VALVE UNIT, YELLOW (MEDIUM): 80-120 mmH2O
• 00382830055864: NATUS DP PEDIATRIC VALVE SYSTEM, WHITE (LOW): 40-80 mmH2O