BD Vacutainer® K2 EDTA (K2E) 5.4mg Blood Collection Tubes 367855

GUDID 30382903678557

TUBE SPC EDTA PLH 13X75 3.0 PLBL TAN SP

BECTON, DICKINSON AND COMPANY

Evacuated blood collection tube IVD, anticoagulant

• Primary Device ID: 30382903678557
• NIH Device Record Key: 13c457ae-ba01-4cd7-9d22-aff937bf5e0d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BD Vacutainer® K2 EDTA (K2E) 5.4mg Blood Collection Tubes
• Version Model Number: 367855
• Catalog Number: 367855
• Company DUNS: 001292192
• Company Name: BECTON, DICKINSON AND COMPANY
• Device Count: 100
• 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: 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00382903678556 [Unit of Use]
GS1	30382903678557 [Primary]
GS1	50382903678551 [Package]; Package: Case [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• BK050036

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: 4
• Public Version Date: 2024-04-01
• Device Publish Date: 2016-07-28

On-Brand Devices [BD Vacutainer® K2 EDTA (K2E) 5.4mg Blood Collection Tubes]

• 30382903678595: TUBE K2EDTA PLH 13X75 3.0 MLBL LAV
• 30382903678359: BD Vacutainer® K2 EDTA 5.4mg
• 30382903678557: TUBE SPC EDTA PLH 13X75 3.0 PLBL TAN SP