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

Devices Manufactured by DYNAREX CORPORATION

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• 00616784040127 - Ridgewood Collection Home Care Bed, Semi-Electric: 2025-06-24 Catalog Number: 10401 Kit: 1 SET OF BOARDS (BOX 2 OF 2)
• 00810180842198 - LabChoice Petri Dishes, Stackable, 90 x 15 mm, Sterile: 2025-06-24 Sterile-EO
• 00810180842204 - LabChoice Petri Dishes, Stackable, Sterile, 150 x 15 mm: 2025-06-24 Sterile-EO
• 00810180842211 - LabChoice Sputum Containers, 40 mL: 2025-06-24 Non-Sterile
• 00810180842228 - DispoSafety Biohazard Bags, 39" x 33", 2 MIL, 33 Gallon: 2025-06-24
• 00810180842235 - DispoSafety Biohazard Bags, 40" x 46", 2 MIL, 45 Gallon: 2025-06-24
• 00810180842242 - DispoSafety Biohazard Bags, 40" x 46", 3 MIL, 45 Gallon: 2025-06-24