Dialysis Safety Syringe w/Needle

GUDID 00616784693231

DYNAREX CORPORATION

Haemodialysis needle

• Primary Device ID: 00616784693231
• NIH Device Record Key: f5558215-948b-4bfb-8d04-bded67c0fb2d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dialysis Safety Syringe w/Needle
• Version Model Number: 6932
• Company DUNS: 008124539
• Company Name: DYNAREX CORPORATION
• Device Count: 100
• 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	00616784693217 [Unit of Use]
GS1	00616784693224 [Primary]
GS1	00616784693231 [Package]; Contains: 00616784693224; Package: [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K052445

FDA Product Code

• FMI: Needle, Hypodermic, Single Lumen

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 [Dialysis Safety Syringe w/Needle]

• 00616784693231: 6932
• 00616784693132: 6931