BD Vacutainer® EDTA (K2) Blood Collection Tubes 366643

GUDID 50382903666435

BD Vacutainer® EDTA (K2) Blood Collection Tubes

Becton, Dickinson U.K. Limited

Evacuated blood collection tube IVD, K2EDTA

• Primary Device ID: 50382903666435
• NIH Device Record Key: e3d98245-746b-45e0-a5c2-29eec5a6405f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BD Vacutainer® EDTA (K2) Blood Collection Tubes
• Version Model Number: 366643
• Catalog Number: 366643
• Company DUNS: 225931062
• Company Name: Becton, Dickinson U.K. Limited
• 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	00382903666430 [Unit of Use]
GS1	30382903666431 [Package]; Package: Shelfpack [100 Units]; In Commercial Distribution
GS1	50382903666435 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• BK050036

FDA Product Code

• GIM: Tubes, vacuum sample, with anticoagulant

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® EDTA (K2) Blood Collection Tubes]

• 50382903666435: BD Vacutainer® EDTA (K2) Blood Collection Tubes
• 30382903666431: TUBE EDTA PLH 16X100 10.0 SLBL USA LAV