BD BACTEC™ Standard/10 Aerobic/F Culture Vials (plastic) 442027

GUDID 30382904420278

BD BACTEC™ Standard/10 Aerobic/F Culture Vials (plastic)

BECTON, DICKINSON AND COMPANY

Aerobic blood culture broth IVD

• Primary Device ID: 30382904420278
• NIH Device Record Key: c997e583-f6e3-48ff-90ab-d895978d1175
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BD BACTEC™ Standard/10 Aerobic/F Culture Vials (plastic)
• Version Model Number: 442027
• Catalog Number: 442027
• Company DUNS: 122561087
• Company Name: BECTON, DICKINSON AND COMPANY
• Device Count: 1
• 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: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)638-8663
• Email: Technical_services@bd.com
• Phone: +1(800)638-8663
• Email: Technical_services@bd.com
• Phone: +1(800)638-8663
• Email: Technical_services@bd.com
• Phone: +1(800)638-8663
• Email: Technical_services@bd.com
• Phone: +1(800)638-8663
• Email: Technical_services@bd.com
• Phone: +1(800)638-8663
• Email: Technical_services@bd.com
• Phone: +1(800)638-8663
• Email: Technical_services@bd.com
• Phone: +1(800)638-8663
• Email: Technical_services@bd.com
• Phone: +1(800)638-8663
• Email: Technical_services@bd.com
• Phone: +1(800)638-8663
• Email: Technical_services@bd.com
• Phone: +1(800)638-8663
• Email: Technical_services@bd.com
• Phone: +1(800)638-8663
• Email: Technical_services@bd.com
• Phone: +1(800)638-8663
• Email: Technical_services@bd.com
• Phone: +1(800)638-8663
• Email: Technical_services@bd.com
• Phone: +1(800)638-8663
• Email: Technical_services@bd.com
• Phone: +1(800)638-8663
• Email: Technical_services@bd.com
• Phone: +1(800)638-8663
• Email: Technical_services@bd.com
• Phone: +1(800)638-8663
• Email: Technical_services@bd.com
• Phone: +1(800)638-8663
• Email: Technical_services@bd.com
• Phone: +1(800)638-8663
• Email: Technical_services@bd.com
• Phone: +1(800)638-8663
• Email: Technical_services@bd.com
• Phone: +1(800)638-8663
• Email: Technical_services@bd.com
• Phone: +1(800)638-8663
• Email: Technical_services@bd.com
• Phone: +1(800)638-8663
• Email: Technical_services@bd.com
• Phone: +1(800)638-8663
• Email: Technical_services@bd.com
• Phone: +1(800)638-8663
• Email: Technical_services@bd.com
• Phone: +1(800)638-8663
• Email: Technical_services@bd.com
• Phone: +1(800)638-8663
• Email: Technical_services@bd.com
• Phone: +1(800)638-8663
• Email: Technical_services@bd.com
• Phone: +1(800)638-8663
• Email: Technical_services@bd.com
• Phone: +1(800)638-8663
• Email: Technical_services@bd.com

Device Dimensions

• Total Volume: 40 Milliliter
• Total Volume: 40 Milliliter
• Total Volume: 40 Milliliter
• Total Volume: 40 Milliliter
• Total Volume: 40 Milliliter
• Total Volume: 40 Milliliter
• Total Volume: 40 Milliliter
• Total Volume: 40 Milliliter
• Total Volume: 40 Milliliter
• Total Volume: 40 Milliliter
• Total Volume: 40 Milliliter
• Total Volume: 40 Milliliter
• Total Volume: 40 Milliliter
• Total Volume: 40 Milliliter
• Total Volume: 40 Milliliter
• Total Volume: 40 Milliliter
• Total Volume: 40 Milliliter
• Total Volume: 40 Milliliter
• Total Volume: 40 Milliliter
• Total Volume: 40 Milliliter
• Total Volume: 40 Milliliter
• Total Volume: 40 Milliliter
• Total Volume: 40 Milliliter
• Total Volume: 40 Milliliter
• Total Volume: 40 Milliliter
• Total Volume: 40 Milliliter
• Total Volume: 40 Milliliter
• Total Volume: 40 Milliliter
• Total Volume: 40 Milliliter
• Total Volume: 40 Milliliter
• Total Volume: 40 Milliliter

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00382904420277 [Primary]
GS1	30382904420278 [Package]; Contains: 00382904420277; Package: Shelfpack [50 Units]; In Commercial Distribution
GS1	60382904420279 [Package]; Package: US pallet [80 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161810

FDA Product Code

• MDB: SYSTEM, BLOOD CULTURING

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-05-25

Devices Manufactured by BECTON, DICKINSON AND COMPANY

• 50382903649803 - BD Vacutainer® Urinalysis Conical Urine Tube: 2025-01-31 TUBE URIN PLC 16X100 8.0 CONI UA YEL
• 50382903667029 - BD Vacutainer® No Additive (Z) Tubes: 2025-01-31 TUBE PLN PLH 13X75 2.5 PLBL
• 50382903247054 - BD Insulin Syringe: 2024-12-16 U-100 Insulin Syringe, 1.0mL, 27G x 12.7mm
• 00382902900207 - BD Sputum Collection System: 2024-11-27 BD Sputum Collection System, Case of 72 units
• 30382902461006 - BD Kiestra™ Isolate Suspension Cuvette Array: 2024-11-27 BD Kiestra™ Isolate Suspension Cuvette Array
• 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