BD Kiestra™ IdentifA 444063

GUDID 00382904440633

BD Kiestra IdentifA

BECTON, DICKINSON AND COMPANY

Microbial specimen inoculation/streaking/colony-picking instrument IVD

• Primary Device ID: 00382904440633
• NIH Device Record Key: dde81aa3-1b1c-49a9-b026-f6b0694c5fc7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BD Kiestra™ IdentifA
• Version Model Number: 444063
• Catalog Number: 444063
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• 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
• 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

• Depth: 860 Millimeter
• Width: 1060 Millimeter
• Weight: 550 Kilogram
• Height: 1700 Millimeter
• Depth: 860 Millimeter
• Width: 1060 Millimeter
• Weight: 550 Kilogram
• Height: 1700 Millimeter
• Depth: 860 Millimeter
• Width: 1060 Millimeter
• Weight: 550 Kilogram
• Height: 1700 Millimeter
• Depth: 860 Millimeter
• Width: 1060 Millimeter
• Weight: 550 Kilogram
• Height: 1700 Millimeter
• Depth: 860 Millimeter
• Width: 1060 Millimeter
• Weight: 550 Kilogram
• Height: 1700 Millimeter
• Depth: 860 Millimeter
• Width: 1060 Millimeter
• Weight: 550 Kilogram
• Height: 1700 Millimeter
• Depth: 860 Millimeter
• Width: 1060 Millimeter
• Weight: 550 Kilogram
• Height: 1700 Millimeter
• Depth: 860 Millimeter
• Width: 1060 Millimeter
• Weight: 550 Kilogram
• Height: 1700 Millimeter
• Depth: 860 Millimeter
• Width: 1060 Millimeter
• Weight: 550 Kilogram
• Height: 1700 Millimeter
• Depth: 860 Millimeter
• Width: 1060 Millimeter
• Weight: 550 Kilogram
• Height: 1700 Millimeter
• Depth: 860 Millimeter
• Width: 1060 Millimeter
• Weight: 550 Kilogram
• Height: 1700 Millimeter
• Depth: 860 Millimeter
• Width: 1060 Millimeter
• Weight: 550 Kilogram
• Height: 1700 Millimeter
• Depth: 860 Millimeter
• Width: 1060 Millimeter
• Weight: 550 Kilogram
• Height: 1700 Millimeter
• Depth: 860 Millimeter
• Width: 1060 Millimeter
• Weight: 550 Kilogram
• Height: 1700 Millimeter
• Depth: 860 Millimeter
• Width: 1060 Millimeter
• Weight: 550 Kilogram
• Height: 1700 Millimeter
• Depth: 860 Millimeter
• Width: 1060 Millimeter
• Weight: 550 Kilogram
• Height: 1700 Millimeter
• Depth: 860 Millimeter
• Width: 1060 Millimeter
• Weight: 550 Kilogram
• Height: 1700 Millimeter
• Depth: 860 Millimeter
• Width: 1060 Millimeter
• Weight: 550 Kilogram
• Height: 1700 Millimeter
• Depth: 860 Millimeter
• Width: 1060 Millimeter
• Weight: 550 Kilogram
• Height: 1700 Millimeter
• Depth: 860 Millimeter
• Width: 1060 Millimeter
• Weight: 550 Kilogram
• Height: 1700 Millimeter
• Depth: 860 Millimeter
• Width: 1060 Millimeter
• Weight: 550 Kilogram
• Height: 1700 Millimeter
• Depth: 860 Millimeter
• Width: 1060 Millimeter
• Weight: 550 Kilogram
• Height: 1700 Millimeter
• Depth: 860 Millimeter
• Width: 1060 Millimeter
• Weight: 550 Kilogram
• Height: 1700 Millimeter
• Depth: 860 Millimeter
• Width: 1060 Millimeter
• Weight: 550 Kilogram
• Height: 1700 Millimeter
• Depth: 860 Millimeter
• Width: 1060 Millimeter
• Weight: 550 Kilogram
• Height: 1700 Millimeter
• Depth: 860 Millimeter
• Width: 1060 Millimeter
• Weight: 550 Kilogram
• Height: 1700 Millimeter
• Depth: 860 Millimeter
• Width: 1060 Millimeter
• Weight: 550 Kilogram
• Height: 1700 Millimeter
• Depth: 860 Millimeter
• Width: 1060 Millimeter
• Weight: 550 Kilogram
• Height: 1700 Millimeter
• Depth: 860 Millimeter
• Width: 1060 Millimeter
• Weight: 550 Kilogram
• Height: 1700 Millimeter
• Depth: 860 Millimeter
• Width: 1060 Millimeter
• Weight: 550 Kilogram
• Height: 1700 Millimeter
• Depth: 860 Millimeter
• Width: 1060 Millimeter
• Weight: 550 Kilogram
• Height: 1700 Millimeter
• Depth: 860 Millimeter
• Width: 1060 Millimeter
• Weight: 550 Kilogram
• Height: 1700 Millimeter
• Depth: 860 Millimeter
• Width: 1060 Millimeter
• Weight: 550 Kilogram
• Height: 1700 Millimeter
• Depth: 860 Millimeter
• Width: 1060 Millimeter
• Weight: 550 Kilogram
• Height: 1700 Millimeter
• Depth: 860 Millimeter
• Width: 1060 Millimeter
• Weight: 550 Kilogram
• Height: 1700 Millimeter
• Depth: 860 Millimeter
• Width: 1060 Millimeter
• Weight: 550 Kilogram
• Height: 1700 Millimeter
• Depth: 860 Millimeter
• Width: 1060 Millimeter
• Weight: 550 Kilogram
• Height: 1700 Millimeter
• Depth: 860 Millimeter
• Width: 1060 Millimeter
• Weight: 550 Kilogram
• Height: 1700 Millimeter
• Depth: 860 Millimeter
• Width: 1060 Millimeter
• Weight: 550 Kilogram
• Height: 1700 Millimeter
• Depth: 860 Millimeter
• Width: 1060 Millimeter
• Weight: 550 Kilogram
• Height: 1700 Millimeter
• Depth: 860 Millimeter
• Width: 1060 Millimeter
• Weight: 550 Kilogram
• Height: 1700 Millimeter
• Depth: 860 Millimeter
• Width: 1060 Millimeter
• Weight: 550 Kilogram
• Height: 1700 Millimeter
• Depth: 860 Millimeter
• Width: 1060 Millimeter
• Weight: 550 Kilogram
• Height: 1700 Millimeter
• Depth: 860 Millimeter
• Width: 1060 Millimeter
• Weight: 550 Kilogram
• Height: 1700 Millimeter
• Depth: 860 Millimeter
• Width: 1060 Millimeter
• Weight: 550 Kilogram
• Height: 1700 Millimeter
• Depth: 860 Millimeter
• Width: 1060 Millimeter
• Weight: 550 Kilogram
• Height: 1700 Millimeter
• Depth: 860 Millimeter
• Width: 1060 Millimeter
• Weight: 550 Kilogram
• Height: 1700 Millimeter
• Depth: 860 Millimeter
• Width: 1060 Millimeter
• Weight: 550 Kilogram
• Height: 1700 Millimeter

Operating and Storage Conditions

• Storage Environment Temperature: Between 18 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 27 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00382904440633 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191964

FDA Product Code

• QBN: Mass spectrometry, MALDI TOF, microorganism identification, cultured isolates

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-06-08
• Device Publish Date: 2023-05-31

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