Safety Insulin Syringes

GUDID 00616784690537

DYNAREX CORPORATION

Insulin syringe/needle, safety Insulin syringe/needle, safety

• Primary Device ID: 00616784690537
• NIH Device Record Key: 0cf53abd-5234-4dfe-a70b-f7b976558e5c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Safety Insulin Syringes
• Version Model Number: 6905
• 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	00616784690513 [Unit of Use]
GS1	00616784690520 [Primary]
GS1	00616784690537 [Package]; Contains: 00616784690520; Package: [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K050131

FDA Product Code

• MEG: Syringe, Antistick

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 [Safety Insulin Syringes]

• 00616784690537: 6905
• 00616784690438: 6904
• 00616784690339: 6903
• 00616784690230: 6902
• 00616784690131: 6901