DEPUY CODMAN SRD5839

GUDID 20886704064869

CATH FR.5 INF . 100CM

CORDIS CORPORATION

Angiographic catheter, single-use

• Primary Device ID: 20886704064869
• NIH Device Record Key: 0288d358-c064-4bf7-8bad-6e9b10005ca7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DEPUY CODMAN
• Version Model Number: SRD5839
• Catalog Number: SRD5839
• 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 *Exposure to temperatures above 54 degrees C (130 F) may damage the catheter
• 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 *Store in cool, dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened or damaged
• 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 *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 *Store in cool, dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened or damaged
• 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 *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 *Store in cool, dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened or damaged
• 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 *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 *Store in cool, dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened or damaged
• 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 *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 *Store in cool, dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened or damaged
• 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 *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 *Store in cool, dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened or damaged
• 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 *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 *Store in cool, dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened or damaged
• 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 *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 *Store in cool, dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened or damaged
• 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 *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 *Store in cool, dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened or damaged
• 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 *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 *Store in cool, dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened or damaged
• 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 *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 *Store in cool, dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened or damaged
• 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 *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 *Store in cool, dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened or damaged
• 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 *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 *Store in cool, dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened or damaged
• 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 *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 *Store in cool, dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened or damaged
• 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 *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 *Store in cool, dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened or damaged
• 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 *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 *Store in cool, dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened or damaged
• 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 *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 *Store in cool, dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened or damaged
• 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 *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 *Store in cool, dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened or damaged
• 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 *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 *Store in cool, dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened or damaged
• 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 *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 *Store in cool, dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened or damaged
• 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 *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 *Store in cool, dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened or damaged
• 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 *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 *Store in cool, dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened or damaged
• 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 *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 *Store in cool, dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened or damaged
• 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 *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 *Store in cool, dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened or damaged
• 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 *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 *Store in cool, dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened or damaged
• 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 *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 *Store in cool, dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened or damaged
• 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 *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 *Store in cool, dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened or damaged
• 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 *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 *Store in cool, dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened or damaged
• 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 *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 *Store in cool, dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened or damaged
• 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 *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 *Store in cool, dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened or damaged
• 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 *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 *Store in cool, dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened or damaged
• 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 *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 *Store in cool, dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened or damaged
• 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 *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 *Store in cool, dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened or damaged
• 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 *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 *Store in cool, dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened or damaged
• 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 *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 *Store in cool, dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened or damaged
• 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 *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 *Store in cool, dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened or damaged
• 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 *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 *Store in cool, dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened or damaged
• 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 *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 *Store in cool, dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened or damaged
• 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 *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 *Store in cool, dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened or damaged
• 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 *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 *Store in cool, dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened or damaged
• 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 *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 *Store in cool, dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened or damaged
• 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 *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 *Store in cool, dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened or damaged
• 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 *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 *Store in cool, dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened or damaged
• 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 *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 *Store in cool, dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened or damaged
• 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 *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 *Store in cool, dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened or damaged
• 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 *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 *Store in cool, dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened or damaged
• 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 *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 *Store in cool, dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened or damaged
• 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 *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 *Store in cool, dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened or damaged

Device Identifiers

Device Issuing Agency	Device ID
GS1	20886704064869 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K914007

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: 2016-09-23

On-Brand Devices [DEPUY CODMAN]

• 20886704064869: CATH FR.5 INF . 100CM
• 20886704044137: ST 6F .038 125CM SIM2
• 20886704044120: ST 4F .035 110CM UCSF 3
• 10886704044130: ST 6F .038 125CM SIM2
• 10886704044123: ST 4F .035 110CM UCSF 3