CODMAN HAKIM HOLTER NS0513

GUDID 10886704045755

CODMAN HAKIM Precision Fixed Pressure Valve with Proximal Tubing and .060 Inch Platform Operating Pressure: 130mm H2O High Range Includes: HOLTER Type "B" Connector, Straight Connector, Priming Adapter and information Manual

CODMAN & SHURTLEFF, INC.

Cerebrospinal fluid shunt valve

• Primary Device ID: 10886704045755
• NIH Device Record Key: b9c85ac1-5ec7-45e5-bef5-1bf8d3874735
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CODMAN HAKIM HOLTER
• Version Model Number: NS0513
• Catalog Number: NS0513
• Company DUNS: 607846297
• Company Name: CODMAN & SHURTLEFF, 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: true
• 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)255-2500
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Device Identifiers

Device Issuing Agency	Device ID
GS1	10886704045755 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K053350

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: 2021-04-07
• Device Publish Date: 2015-09-20

On-Brand Devices [CODMAN HAKIM HOLTER]

• 10886704045755: CODMAN HAKIM Precision Fixed Pressure Valve with Proximal Tubing and .060 Inch Platform Operatin
• 10886704045748: CODMAN HAKIM Precision Fixed Pressure Valve with Proximal Tubing and .060 Inch Platform Operatin
• 10886704045731: CODMAN HAKIM Precision Fixed Pressure Valve with Proximal Tubing and .060 Inch Platform Operatin
• 10886704045724: CODMAN HAKIM Precision Fixed Pressure Valve with Proximal Tubing and .060 Inch Platform Operatin
• 10886704045717: CODMAN HAKIM Precision Fixed Pressure Valve with Proximal Tubing and .060 Inch Platform Operatin