BD Vacutainer® Sodium Fluoride Potassium Oxalate 5 367921

GUDID 50382903679213

BD Vacutainer® Sodium Fluoride Potassium Oxalate 5mg/4mg

BECTON, DICKINSON AND COMPANY

Evacuated blood collection tube IVD, potassium oxalate/sodium fluoride

• Primary Device ID: 50382903679213
• NIH Device Record Key: e435a24e-b007-4503-863c-ae6e51bfb6f5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BD Vacutainer® Sodium Fluoride Potassium Oxalate 5
• Version Model Number: 367921
• Catalog Number: 367921
• Company DUNS: 001292192
• Company Name: BECTON, DICKINSON AND COMPANY
• Device Count: 1000
• DM Exempt: true
• 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: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00382903679218 [Unit of Use]
GS1	50382903679213 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K945952

FDA Product Code

• JKA: Tubes, vials, systems, serum separators, blood collection

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: 2016-08-22

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