CODMAN HAKIM SIPHONGUARD HOLTER 823854

GUDID 10886704041900

CODMAN HAKIM Programmable Valve In-Line Valve SIPHONGUARD Device, .060 Inch Platform and Unitized Distal Catheter Operating Pressure: 30mm H2O to 200mm H2O (294 Pa - 1960 Pa) programmable in steps of 10mm H2O (98 Pa) Includes: Ventricular Catheter 14cm, Stylet, Right Angle Adaptor, Straight Connector, HOLTER Type B Connector, Priming Adaptor and Information Manual

CODMAN & SHURTLEFF, INC.

Ventriculo-peritoneal/atrial shunt

• Primary Device ID: 10886704041900
• NIH Device Record Key: eabfd9f9-3f2a-491d-849d-1f6c4fb1571f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CODMAN HAKIM SIPHONGUARD HOLTER
• Version Model Number: 82-3854
• Catalog Number: 823854
• Company DUNS: 607846297
• Company Name: CODMAN & SHURTLEFF, INC.
• 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: 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

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Device Identifiers

Device Issuing Agency	Device ID
GS1	10886704041900 [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

Devices Manufactured by CODMAN & SHURTLEFF, INC.

• 10886704085355 - CEREGLIDE: 2023-07-17 CEREGLIDE 71 Intermediate Catheter 115 cm 0.071 in (1.80 mm) 0.0820 in (2.08 mm) 0.0825 in (2.10 mm)
• 10886704085386 - CEREGLIDE: 2023-07-17 CEREGLIDE 71 Intermediate Catheter 137 cm 0.071 in (1.80 mm) 0.0820 in (2.08 mm) 0.0825 in (2.10 mm)
• 10886704085409 - CEREGLIDE: 2023-07-17 CEREGLIDE 71 Intermediate Catheter 132 cm 0.071 in (1.80 mm) 0.0820 in (2.08 mm) 0.0825 in (2.10 mm)
• 10886704085423 - CEREGLIDE: 2023-07-17 CEREGLIDE 71 Intermediate Catheter 125 cm 0.071 in (1.80 mm) 0.0820 in (2.08 mm) 0.0825 in (2.10 mm)
• 10886704078630 - CODMAN MALIS CMC: 2023-04-04 CODMAN MALIS CMC-V Generator
• 10886704046912 - CODMAN HAKIM RICKHAM: 2022-10-10 CODMAN HAKIM Precision Fixed Pressure Valve MICRO II With Large RICKHAM Reservoir Operating Pressure: 100mm H2O Plus or Minus 10
• 10886704045366 - CODMAN HAKIM SIPHONGUARD: 2022-09-01 CODMAN HAKIM Precision Fixed Pressure Valve with SIPHONGUARD Device Operating Pressure: 130mm H2O High Range Includes: Ventricul
• 10886704015505 - CRANIOPLASTIC: 2022-03-01 Codman CRANIOPLASTIC Resinous Material for Repairing Cranial Defects