Microtainer® K2E Blood Collection Tubes 365975

GUDID 50382903659758

TUBE MICRO W/MICROGARD EDTA LAV

BECTON, DICKINSON AND COMPANY

Evacuated blood collection tube IVD, anticoagulant Evacuated blood collection tube IVD, anticoagulant Evacuated blood collection tube IVD, anticoagulant Evacuated blood collection tube IVD, anticoagulant Evacuated blood collection tube IVD, anticoagulant Evacuated blood collection tube IVD, anticoagulant Evacuated blood collection tube IVD, anticoagulant

• Primary Device ID: 50382903659758
• NIH Device Record Key: 2ac9e507-90c8-4630-8749-1de38572ddb1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Microtainer® K2E Blood Collection Tubes
• Version Model Number: 365975
• Catalog Number: 365975
• Company DUNS: 001292192
• Company Name: BECTON, DICKINSON AND COMPANY
• Device Count: 50
• 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: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00382903659753 [Unit of Use]
GS1	30382903659754 [Primary]
GS1	50382903659758 [Package]; Contains: 30382903659754; Package: Case [4 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K940905

FDA Product Code

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

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-04-15
• Device Publish Date: 2024-04-05

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