Allergy Tray

GUDID 00616784693637

DYNAREX CORPORATION

Hypodermic needle, single-use Hypodermic needle, single-use

• Primary Device ID: 00616784693637
• NIH Device Record Key: 34fbd204-5ec8-46dc-a6e8-00dfdafc9764
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Allergy Tray
• Version Model Number: 6936
• Company DUNS: 008124539
• Company Name: DYNAREX CORPORATION
• Device Count: 25
• 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	00616784693606 [Unit of Use]
GS1	00616784693613 [Primary]
GS1	00616784693637 [Package]; Contains: 00616784693613; Package: Master Case [40 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K113091

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: 5
• Public Version Date: 2019-10-23
• Device Publish Date: 2017-09-08

Devices Manufactured by DYNAREX CORPORATION

• 08401173287854 - DynaCare Tampons,Super,Plastic Applicator: 2024-04-17 Unscented, Free of Dyes & Perfumes
• 00860008059512 - IV Start Kit: 2024-04-10
• 00840117333215 - Instant Cold Pack, 4" x 5": 2024-04-08 For use whenever instant cold therapy is required
• 00616784046617 - Homecare Half Length Bed Rail Cross Bar Mount: 2024-04-05
• 00616784706313 - IV Extension Sets Needle-Free Luer Lock Connector for Injection Non-Toxic: 2024-04-02 15" , Sterile
• 00840117333000 - XeroBurn Sterile Burn Dressing Blanket: 2024-04-02 30" x 35"
• 00840117333024 - XeroBurn Sterile Burn Dressing Blanket 60"x 70": 2024-04-02 60"x 70"
• 00840117333048 - XeroBurn Sterile Burn Dressing Blanket 70" x 95": 2024-04-02 70" x 95"