BD Vacutainer® ACD Solution B 364816

GUDID 50382903648165

BD Vacutainer® ACD Solution B

BECTON, DICKINSON AND COMPANY

Evacuated blood collection tube IVD, acid citrate dextrose B (ACD-B)

• Primary Device ID: 50382903648165
• NIH Device Record Key: 29428cd5-32b1-4113-81f3-98e3509d90ae
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BD Vacutainer® ACD Solution B
• Version Model Number: 364816
• Catalog Number: 364816
• Company DUNS: 001292192
• Company Name: BECTON, DICKINSON AND COMPANY
• Device Count: 1000
• DM Exempt: false
• Pre-market Exempt: true
• 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	00382903648160 [Unit of Use]
GS1	30382903648161 [Package]; Package: Shelfpack [100 Units]; In Commercial Distribution
GS1	50382903648165 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• BK210649

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: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-07-28

Devices Manufactured by BECTON, DICKINSON AND COMPANY

• 50382903032780 - Eclipse Needle: 2024-11-21 NEEDLE ECLIPSE 23X1-1/2 RB TW BNS
• 60382904454755 - BD BACTEC™ 9240: 2024-11-12 BD BACTEC™ 9240
• 60382904455707 - BD BACTEC™ 9120: 2024-11-12 BD BACTEC™ 9120
• 00382904458003 - BD BACTEC™ 9050: 2024-11-11 BD BACTEC™ 9050
• 00382904454166 - BD Onclarity HPV Self Collection Diluent Tube: 2024-11-11 BD Onclarity HPV Self Collection Diluent Tube
• 00382906639844 - Horizon: 2024-10-22 CD138 (MI15) BV421 ASR
• 00382906651204 - Horizon: 2024-10-22 CD197 (2-L1-A) APC-R700 ASR
• 00382906651297 - Horizon: 2024-10-22 CD194 (1G1) BV421 ASR