INFINITI SR4984

GUDID 20705032046838

5 F INF 0.038 125CM JL4

CORDIS CORPORATION

Angiographic catheter, single-use

• Primary Device ID: 20705032046838
• NIH Device Record Key: 87f44313-f3d1-43af-88b7-b15431ed722a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: INFINITI
• Version Model Number: SR4984
• Catalog Number: SR4984
• Company DUNS: 806136177
• Company Name: CORDIS CORPORATION
• 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

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *To prevent damage to the catheter tip during removal from the package, grasp the hub and withdraw the catheter
• Special Storage Condition, Specify: Between 0 and 0 *Exposure to temperatures above 54 degrees C (130 F) may damage the catheter
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damanged
• Special Storage Condition, Specify: Between 0 and 0 *To prevent damage to the catheter tip during removal from the package, grasp the hub and withdraw the catheter
• Special Storage Condition, Specify: Between 0 and 0 *Exposure to temperatures above 54 degrees C (130 F) may damage the catheter
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damanged
• Special Storage Condition, Specify: Between 0 and 0 *To prevent damage to the catheter tip during removal from the package, grasp the hub and withdraw the catheter
• Special Storage Condition, Specify: Between 0 and 0 *Exposure to temperatures above 54 degrees C (130 F) may damage the catheter
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damanged
• Special Storage Condition, Specify: Between 0 and 0 *To prevent damage to the catheter tip during removal from the package, grasp the hub and withdraw the catheter
• Special Storage Condition, Specify: Between 0 and 0 *Exposure to temperatures above 54 degrees C (130 F) may damage the catheter
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damanged
• Special Storage Condition, Specify: Between 0 and 0 *To prevent damage to the catheter tip during removal from the package, grasp the hub and withdraw the catheter
• Special Storage Condition, Specify: Between 0 and 0 *Exposure to temperatures above 54 degrees C (130 F) may damage the catheter
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damanged
• Special Storage Condition, Specify: Between 0 and 0 *To prevent damage to the catheter tip during removal from the package, grasp the hub and withdraw the catheter
• Special Storage Condition, Specify: Between 0 and 0 *Exposure to temperatures above 54 degrees C (130 F) may damage the catheter
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damanged
• Special Storage Condition, Specify: Between 0 and 0 *To prevent damage to the catheter tip during removal from the package, grasp the hub and withdraw the catheter
• Special Storage Condition, Specify: Between 0 and 0 *Exposure to temperatures above 54 degrees C (130 F) may damage the catheter
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damanged
• Special Storage Condition, Specify: Between 0 and 0 *To prevent damage to the catheter tip during removal from the package, grasp the hub and withdraw the catheter
• Special Storage Condition, Specify: Between 0 and 0 *Exposure to temperatures above 54 degrees C (130 F) may damage the catheter
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damanged
• Special Storage Condition, Specify: Between 0 and 0 *To prevent damage to the catheter tip during removal from the package, grasp the hub and withdraw the catheter
• Special Storage Condition, Specify: Between 0 and 0 *Exposure to temperatures above 54 degrees C (130 F) may damage the catheter
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damanged
• Special Storage Condition, Specify: Between 0 and 0 *To prevent damage to the catheter tip during removal from the package, grasp the hub and withdraw the catheter
• Special Storage Condition, Specify: Between 0 and 0 *Exposure to temperatures above 54 degrees C (130 F) may damage the catheter
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damanged
• Special Storage Condition, Specify: Between 0 and 0 *To prevent damage to the catheter tip during removal from the package, grasp the hub and withdraw the catheter
• Special Storage Condition, Specify: Between 0 and 0 *Exposure to temperatures above 54 degrees C (130 F) may damage the catheter
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damanged
• Special Storage Condition, Specify: Between 0 and 0 *To prevent damage to the catheter tip during removal from the package, grasp the hub and withdraw the catheter
• Special Storage Condition, Specify: Between 0 and 0 *Exposure to temperatures above 54 degrees C (130 F) may damage the catheter
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damanged
• Special Storage Condition, Specify: Between 0 and 0 *To prevent damage to the catheter tip during removal from the package, grasp the hub and withdraw the catheter
• Special Storage Condition, Specify: Between 0 and 0 *Exposure to temperatures above 54 degrees C (130 F) may damage the catheter
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damanged
• Special Storage Condition, Specify: Between 0 and 0 *To prevent damage to the catheter tip during removal from the package, grasp the hub and withdraw the catheter
• Special Storage Condition, Specify: Between 0 and 0 *Exposure to temperatures above 54 degrees C (130 F) may damage the catheter
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damanged
• Special Storage Condition, Specify: Between 0 and 0 *To prevent damage to the catheter tip during removal from the package, grasp the hub and withdraw the catheter
• Special Storage Condition, Specify: Between 0 and 0 *Exposure to temperatures above 54 degrees C (130 F) may damage the catheter
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damanged
• Special Storage Condition, Specify: Between 0 and 0 *To prevent damage to the catheter tip during removal from the package, grasp the hub and withdraw the catheter
• Special Storage Condition, Specify: Between 0 and 0 *Exposure to temperatures above 54 degrees C (130 F) may damage the catheter
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damanged
• Special Storage Condition, Specify: Between 0 and 0 *To prevent damage to the catheter tip during removal from the package, grasp the hub and withdraw the catheter
• Special Storage Condition, Specify: Between 0 and 0 *Exposure to temperatures above 54 degrees C (130 F) may damage the catheter
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damanged
• Special Storage Condition, Specify: Between 0 and 0 *To prevent damage to the catheter tip during removal from the package, grasp the hub and withdraw the catheter
• Special Storage Condition, Specify: Between 0 and 0 *Exposure to temperatures above 54 degrees C (130 F) may damage the catheter
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damanged
• Special Storage Condition, Specify: Between 0 and 0 *To prevent damage to the catheter tip during removal from the package, grasp the hub and withdraw the catheter
• Special Storage Condition, Specify: Between 0 and 0 *Exposure to temperatures above 54 degrees C (130 F) may damage the catheter
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damanged
• Special Storage Condition, Specify: Between 0 and 0 *To prevent damage to the catheter tip during removal from the package, grasp the hub and withdraw the catheter
• Special Storage Condition, Specify: Between 0 and 0 *Exposure to temperatures above 54 degrees C (130 F) may damage the catheter
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damanged
• Special Storage Condition, Specify: Between 0 and 0 *To prevent damage to the catheter tip during removal from the package, grasp the hub and withdraw the catheter
• Special Storage Condition, Specify: Between 0 and 0 *Exposure to temperatures above 54 degrees C (130 F) may damage the catheter
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damanged
• Special Storage Condition, Specify: Between 0 and 0 *To prevent damage to the catheter tip during removal from the package, grasp the hub and withdraw the catheter
• Special Storage Condition, Specify: Between 0 and 0 *Exposure to temperatures above 54 degrees C (130 F) may damage the catheter
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damanged
• Special Storage Condition, Specify: Between 0 and 0 *To prevent damage to the catheter tip during removal from the package, grasp the hub and withdraw the catheter
• Special Storage Condition, Specify: Between 0 and 0 *Exposure to temperatures above 54 degrees C (130 F) may damage the catheter
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damanged
• Special Storage Condition, Specify: Between 0 and 0 *To prevent damage to the catheter tip during removal from the package, grasp the hub and withdraw the catheter
• Special Storage Condition, Specify: Between 0 and 0 *Exposure to temperatures above 54 degrees C (130 F) may damage the catheter
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damanged
• Special Storage Condition, Specify: Between 0 and 0 *To prevent damage to the catheter tip during removal from the package, grasp the hub and withdraw the catheter
• Special Storage Condition, Specify: Between 0 and 0 *Exposure to temperatures above 54 degrees C (130 F) may damage the catheter
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damanged
• Special Storage Condition, Specify: Between 0 and 0 *To prevent damage to the catheter tip during removal from the package, grasp the hub and withdraw the catheter
• Special Storage Condition, Specify: Between 0 and 0 *Exposure to temperatures above 54 degrees C (130 F) may damage the catheter
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damanged
• Special Storage Condition, Specify: Between 0 and 0 *To prevent damage to the catheter tip during removal from the package, grasp the hub and withdraw the catheter
• Special Storage Condition, Specify: Between 0 and 0 *Exposure to temperatures above 54 degrees C (130 F) may damage the catheter
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damanged
• Special Storage Condition, Specify: Between 0 and 0 *To prevent damage to the catheter tip during removal from the package, grasp the hub and withdraw the catheter
• Special Storage Condition, Specify: Between 0 and 0 *Exposure to temperatures above 54 degrees C (130 F) may damage the catheter
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damanged
• Special Storage Condition, Specify: Between 0 and 0 *To prevent damage to the catheter tip during removal from the package, grasp the hub and withdraw the catheter
• Special Storage Condition, Specify: Between 0 and 0 *Exposure to temperatures above 54 degrees C (130 F) may damage the catheter
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damanged
• Special Storage Condition, Specify: Between 0 and 0 *To prevent damage to the catheter tip during removal from the package, grasp the hub and withdraw the catheter
• Special Storage Condition, Specify: Between 0 and 0 *Exposure to temperatures above 54 degrees C (130 F) may damage the catheter
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damanged
• Special Storage Condition, Specify: Between 0 and 0 *To prevent damage to the catheter tip during removal from the package, grasp the hub and withdraw the catheter
• Special Storage Condition, Specify: Between 0 and 0 *Exposure to temperatures above 54 degrees C (130 F) may damage the catheter
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damanged
• Special Storage Condition, Specify: Between 0 and 0 *To prevent damage to the catheter tip during removal from the package, grasp the hub and withdraw the catheter
• Special Storage Condition, Specify: Between 0 and 0 *Exposure to temperatures above 54 degrees C (130 F) may damage the catheter
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damanged
• Special Storage Condition, Specify: Between 0 and 0 *To prevent damage to the catheter tip during removal from the package, grasp the hub and withdraw the catheter
• Special Storage Condition, Specify: Between 0 and 0 *Exposure to temperatures above 54 degrees C (130 F) may damage the catheter
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damanged
• Special Storage Condition, Specify: Between 0 and 0 *To prevent damage to the catheter tip during removal from the package, grasp the hub and withdraw the catheter
• Special Storage Condition, Specify: Between 0 and 0 *Exposure to temperatures above 54 degrees C (130 F) may damage the catheter
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damanged
• Special Storage Condition, Specify: Between 0 and 0 *To prevent damage to the catheter tip during removal from the package, grasp the hub and withdraw the catheter
• Special Storage Condition, Specify: Between 0 and 0 *Exposure to temperatures above 54 degrees C (130 F) may damage the catheter
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damanged
• Special Storage Condition, Specify: Between 0 and 0 *To prevent damage to the catheter tip during removal from the package, grasp the hub and withdraw the catheter
• Special Storage Condition, Specify: Between 0 and 0 *Exposure to temperatures above 54 degrees C (130 F) may damage the catheter
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damanged
• Special Storage Condition, Specify: Between 0 and 0 *To prevent damage to the catheter tip during removal from the package, grasp the hub and withdraw the catheter
• Special Storage Condition, Specify: Between 0 and 0 *Exposure to temperatures above 54 degrees C (130 F) may damage the catheter
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damanged
• Special Storage Condition, Specify: Between 0 and 0 *To prevent damage to the catheter tip during removal from the package, grasp the hub and withdraw the catheter
• Special Storage Condition, Specify: Between 0 and 0 *Exposure to temperatures above 54 degrees C (130 F) may damage the catheter
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damanged
• Special Storage Condition, Specify: Between 0 and 0 *To prevent damage to the catheter tip during removal from the package, grasp the hub and withdraw the catheter
• Special Storage Condition, Specify: Between 0 and 0 *Exposure to temperatures above 54 degrees C (130 F) may damage the catheter
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damanged
• Special Storage Condition, Specify: Between 0 and 0 *To prevent damage to the catheter tip during removal from the package, grasp the hub and withdraw the catheter
• Special Storage Condition, Specify: Between 0 and 0 *Exposure to temperatures above 54 degrees C (130 F) may damage the catheter
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damanged
• Special Storage Condition, Specify: Between 0 and 0 *To prevent damage to the catheter tip during removal from the package, grasp the hub and withdraw the catheter
• Special Storage Condition, Specify: Between 0 and 0 *Exposure to temperatures above 54 degrees C (130 F) may damage the catheter
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damanged
• Special Storage Condition, Specify: Between 0 and 0 *To prevent damage to the catheter tip during removal from the package, grasp the hub and withdraw the catheter
• Special Storage Condition, Specify: Between 0 and 0 *Exposure to temperatures above 54 degrees C (130 F) may damage the catheter
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damanged
• Special Storage Condition, Specify: Between 0 and 0 *To prevent damage to the catheter tip during removal from the package, grasp the hub and withdraw the catheter
• Special Storage Condition, Specify: Between 0 and 0 *Exposure to temperatures above 54 degrees C (130 F) may damage the catheter
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damanged
• Special Storage Condition, Specify: Between 0 and 0 *To prevent damage to the catheter tip during removal from the package, grasp the hub and withdraw the catheter
• Special Storage Condition, Specify: Between 0 and 0 *Exposure to temperatures above 54 degrees C (130 F) may damage the catheter
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damanged
• Special Storage Condition, Specify: Between 0 and 0 *To prevent damage to the catheter tip during removal from the package, grasp the hub and withdraw the catheter
• Special Storage Condition, Specify: Between 0 and 0 *Exposure to temperatures above 54 degrees C (130 F) may damage the catheter
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damanged
• Special Storage Condition, Specify: Between 0 and 0 *To prevent damage to the catheter tip during removal from the package, grasp the hub and withdraw the catheter
• Special Storage Condition, Specify: Between 0 and 0 *Exposure to temperatures above 54 degrees C (130 F) may damage the catheter
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damanged
• Special Storage Condition, Specify: Between 0 and 0 *To prevent damage to the catheter tip during removal from the package, grasp the hub and withdraw the catheter
• Special Storage Condition, Specify: Between 0 and 0 *Exposure to temperatures above 54 degrees C (130 F) may damage the catheter
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damanged
• Special Storage Condition, Specify: Between 0 and 0 *To prevent damage to the catheter tip during removal from the package, grasp the hub and withdraw the catheter
• Special Storage Condition, Specify: Between 0 and 0 *Exposure to temperatures above 54 degrees C (130 F) may damage the catheter
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damanged
• Special Storage Condition, Specify: Between 0 and 0 *To prevent damage to the catheter tip during removal from the package, grasp the hub and withdraw the catheter
• Special Storage Condition, Specify: Between 0 and 0 *Exposure to temperatures above 54 degrees C (130 F) may damage the catheter
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damanged

Device Identifiers

Device Issuing Agency	Device ID
GS1	20705032046838 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K970854

FDA Product Code

• DQO: CATHETER, INTRAVASCULAR, DIAGNOSTIC

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-08-01

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