Secure Safe Allergy Tray

GUDID 00616784893631

DYNAREX CORPORATION

Insulin syringe/needle, safety

• Primary Device ID: 00616784893631
• NIH Device Record Key: 0ef1d897-56f5-421c-9c24-f47fedbdd9a5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Secure Safe Allergy Tray
• Version Model Number: 8936
• Company DUNS: 008124539
• Company Name: DYNAREX CORPORATION
• Device Count: 40
• 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	00616784893617 [Unit of Use]
GS1	00616784893631 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150758

FDA Product Code

• FMF: Syringe, Piston

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: 2017-10-11

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• 00810180842068 - DynaCare Maxi Pads, Ultra-Thin With Wings, Aluminum Foil Wrap: 2025-06-11
• 00840117342118 - Mattress Gap Filler, 4" x 6" x 36": 2025-06-11
• 00840117342125 - Mattress Gap Filler, 4" x 6" x 42": 2025-06-11
• 00840117342132 - Mattress Gap Filler, 4" x 6" x 48": 2025-06-11
• 00840117342149 - Mattress Gap Filler, 6" x 6" x 36": 2025-06-11