BD Vacutainer® K2 EDTA 3.6 mg 367841

GUDID 50382903678414

BD Vacutainer® K2 EDTA 3.6 mg

BECTON, DICKINSON AND COMPANY

Evacuated blood collection tube IVD, K2EDTA Evacuated blood collection tube IVD, K2EDTA 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 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 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: 50382903678414
• NIH Device Record Key: 6c14d034-894e-4335-8d9b-287fba9ca0da
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BD Vacutainer® K2 EDTA 3.6 mg
• Version Model Number: 367841
• Catalog Number: 367841
• Company DUNS: 001292192
• Company Name: BECTON, DICKINSON AND COMPANY
• Device Count: 1000
• 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
• 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	00382903678419 [Unit of Use]
GS1	30382903678410 [Package]; Package: Shelfpack [100 Units]; In Commercial Distribution
GS1	50382903678414 [Primary]

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-07-28

On-Brand Devices [BD Vacutainer® K2 EDTA 3.6 mg]

• 50382903680479: BD Vacutainer® K2 EDTA 3.6 mg
• 50382903678414: BD Vacutainer® K2 EDTA 3.6 mg
• 30382903678410: TUBE K2EDTA PLH 13X75 2.0 PLBL LAV