Intermittent Catheter

GUDID 00616784498133

DYNAREX CORPORATION

Single-administration urethral drainage/irrigation catheter

• Primary Device ID: 00616784498133
• NIH Device Record Key: cff851dd-355e-43b6-b9fd-2163cf0a7d70
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Intermittent Catheter
• Version Model Number: 4981
• Company DUNS: 008124539
• Company Name: DYNAREX CORPORATION
• Device Count: 50
• 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: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00616784498119 [Unit of Use]
GS1	00616784498126 [Primary]
GS1	00616784498133 [Package]; Contains: 00616784498126; Package: [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K103086

FDA Product Code

• EZD: Catheter, Straight

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: 2018-07-06
• Device Publish Date: 2016-09-24

On-Brand Devices [Intermittent Catheter]

• 00616784499536: 4995
• 00616784499437: 4994
• 00616784499338: 4993
• 00616784499239: 4992
• 00616784499130: 4991
• 00616784498638: 4986
• 00616784498539: 4985
• 00616784498430: 4984
• 00616784498331: 4983
• 00616784498232: 4982
• 00616784498133: 4981