CODMAN HAKIM BACTISEAL SIPHONGUARD RICKHAM NS5514

GUDID 10886704048411

CODMAN HAKIM Precision Fixed Pressure Valve with BACTISEAL with SIPHONGUARD Device, Unitized RICKHAM Reservoir, Stainless Steel Base and Bactiseal Catheters Operating Pressure: 100mm H2O (980Pa) Medium High Range Includes: BACTISEAL Ventricular Catheter 14cm, Stylet, Unitized BACTISEAL Peritoneal Catheter 120cm, Priming Adapter and Information Manual

CODMAN & SHURTLEFF, INC.

Ventriculoperitoneal shunt

• Primary Device ID: 10886704048411
• NIH Device Record Key: 11a858b8-ac4a-45c5-a56a-eb4797a0e817
• Commercial Distribution Discontinuation: 2022-09-01
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CODMAN HAKIM BACTISEAL SIPHONGUARD RICKHAM
• Version Model Number: NS5514
• Catalog Number: NS5514
• 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: true
• 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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• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
• Email: xx@xx.xx

Operating and Storage Conditions

• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Handling Environment Temperature: Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Handling Environment Temperature: Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Handling Environment Temperature: Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Handling Environment Temperature: Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Handling Environment Temperature: Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Handling Environment Temperature: Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Handling Environment Temperature: Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Handling Environment Temperature: Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Handling Environment Temperature: Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Handling Environment Temperature: Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Handling Environment Temperature: Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Handling Environment Temperature: Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Handling Environment Temperature: Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Handling Environment Temperature: Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Handling Environment Temperature: Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Handling Environment Temperature: Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Handling Environment Temperature: Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Handling Environment Temperature: Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Handling Environment Temperature: Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Handling Environment Temperature: Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Handling Environment Temperature: Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Handling Environment Temperature: Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Handling Environment Temperature: Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Handling Environment Temperature: Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Handling Environment Temperature: Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Handling Environment Temperature: Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Handling Environment Temperature: Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Handling Environment Temperature: Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Handling Environment Temperature: Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Handling Environment Temperature: Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Handling Environment Temperature: Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Handling Environment Temperature: Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Handling Environment Temperature: Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Handling Environment Temperature: Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Handling Environment Temperature: Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Handling Environment Temperature: Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Handling Environment Temperature: Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Handling Environment Temperature: Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Handling Environment Temperature: Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Handling Environment Temperature: Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Handling Environment Temperature: Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Handling Environment Temperature: Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Handling Environment Temperature: Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Handling Environment Temperature: Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Handling Environment Temperature: Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Handling Environment Temperature: Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Handling Environment Temperature: Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Handling Environment Temperature: Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Handling Environment Temperature: Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Handling Environment Temperature: Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	10886704048411 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K091346

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: 5
• Public Version Date: 2021-10-12
• Device Publish Date: 2015-09-20

On-Brand Devices [CODMAN HAKIM BACTISEAL SIPHONGUARD RICKHAM]

• 10886704048428: CODMAN HAKIM Precision Fixed Pressure Valve with BACTISEAL with SIPHONGUARD Device, Unitized RIC
• 10886704048411: CODMAN HAKIM Precision Fixed Pressure Valve with BACTISEAL with SIPHONGUARD Device, Unitized RIC
• 10886704048404: CODMAN HAKIM Precision Fixed Pressure Valve with BACTISEAL with SIPHONGUARD Device, Unitized RIC
• 10886704048398: CODMAN HAKIM Precision Fixed Pressure Valve with BACTISEAL with SIPHONGUARD Device, Unitized RIC
• 10886704048381: CODMAN HAKIM Precision Fixed Pressure Valve with BACTISEAL with SIPHONGUARD Device, Unitized RIC