8943 SecureSafe Safety Blood Collection Set w/ Tube Holder, 21G, 3/4" Needle, 4/

GUDID 00616784894331

DYNAREX CORPORATION

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• Primary Device ID: 00616784894331
• NIH Device Record Key: e4dee758-6597-44f0-aad0-28abc636a562
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 8943 SecureSafe Safety Blood Collection Set w/ Tube Holder, 21G, 3/4" Needle, 4/
• Version Model Number: 8943
• Company DUNS: 008124539
• Company Name: DYNAREX CORPORATION
• Device Count: 200
• 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	00616784894317 [Unit of Use]
GS1	00616784894331 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-10-15
• Device Publish Date: 2018-09-13

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