Secure Safe Safety Blood Collection Set, Sterile, 21GF,3/4" Needle

GUDID 00616784894010

DYNAREX CORPORATION

Blood collection needle

• Primary Device ID: 00616784894010
• NIH Device Record Key: 13d9a659-f47e-4a34-b932-bf9ee85ea5e9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Secure Safe Safety Blood Collection Set, Sterile, 21GF,3/4" Needle
• Version Model Number: 8940
• Company DUNS: 008124539
• Company Name: DYNAREX CORPORATION
• Device Count: 1
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00616784894010 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151991

FDA Product Code

• FPA: Set, Administration, Intravascular

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: 2019-01-08
• Device Publish Date: 2018-05-26

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