BD 663028

GUDID 00382906630285

Trucount Absolute Counting Tubes US-IVD

BECTON, DICKINSON AND COMPANY

Multiple CD cell marker IVD, control Multiple CD cell marker IVD, control Multiple CD cell marker IVD, control Multiple CD cell marker IVD, control Multiple CD cell marker IVD, control Multiple CD cell marker IVD, control Multiple CD cell marker IVD, control Multiple CD cell marker IVD, control Multiple CD cell marker IVD, control Multiple CD cell marker IVD, control Multiple CD cell marker IVD, control Multiple CD cell marker IVD, control Multiple CD cell marker IVD, control Multiple CD cell marker IVD, control Multiple CD cell marker IVD, control Multiple CD cell marker IVD, control Multiple CD cell marker IVD, control Multiple CD cell marker IVD, control Multiple CD cell marker IVD, control

• Primary Device ID: 00382906630285
• NIH Device Record Key: 7b4eb971-b8cc-48ce-9e68-cf65c8ab2261
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BD
• Version Model Number: 663028
• Catalog Number: 663028
• Company DUNS: 024230633
• 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: 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

Customer Support Contacts

• Phone: +1(877)232-8995
• Email: BDBCustomerService@bd.com
• Phone: +1(877)232-8995
• Email: BDBCustomerService@bd.com
• Phone: +1(877)232-8995
• Email: BDBCustomerService@bd.com
• Phone: +1(877)232-8995
• Email: BDBCustomerService@bd.com
• Phone: +1(877)232-8995
• Email: BDBCustomerService@bd.com
• Phone: +1(877)232-8995
• Email: BDBCustomerService@bd.com
• Phone: +1(877)232-8995
• Email: BDBCustomerService@bd.com
• Phone: +1(877)232-8995
• Email: BDBCustomerService@bd.com
• Phone: +1(877)232-8995
• Email: BDBCustomerService@bd.com
• Phone: +1(877)232-8995
• Email: BDBCustomerService@bd.com
• Phone: +1(877)232-8995
• Email: BDBCustomerService@bd.com
• Phone: +1(877)232-8995
• Email: BDBCustomerService@bd.com
• Phone: +1(877)232-8995
• Email: BDBCustomerService@bd.com
• Phone: +1(877)232-8995
• Email: BDBCustomerService@bd.com
• Phone: +1(877)232-8995
• Email: BDBCustomerService@bd.com
• Phone: +1(877)232-8995
• Email: BDBCustomerService@bd.com
• Phone: +1(877)232-8995
• Email: BDBCustomerService@bd.com
• Phone: +1(877)232-8995
• Email: BDBCustomerService@bd.com
• Phone: +1(877)232-8995
• Email: BDBCustomerService@bd.com

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00382906630285 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K970836

FDA Product Code

• GKZ: Counter, differential cell

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-01-10

On-Brand Devices [BD]

• 00382906630285: Trucount Absolute Counting Tubes US-IVD
• 00382906629951: Multitest 6-color TBNK w/Trucount US-IVD
• 00382906629678: Multitest 6-color TBNK Reagent US-IVD
• 00382906629654: Multitest IMK Kit 50 Tests US-IVD
• 00382906629616: Kit FC Beads 7 Color US IVD
• 00382906624147: CST beads 150T IVD DI (01) 00382906624147, CS&T beads (generic IVD) DI (01) 00382906626493
• 00382906624130: CST beads 50T IVD
• 00382903497058: Multi-Check CD4 Low Ctrl 5X2.5mL US-IVD DI 00382903497058, BD MultiCheck CD4 Low Ctrl Vial UDI D
• 00382903497041: Multi-Check CD4 Low Ctrl 2X2.5mL US-IVD DI 00382903497041, BD MultiCheck CD4 Low Ctrl Vial UDI D
• 00382903497034: Multi-Check CD4 Low Ctrl 1X2.5mL US-IVD DI 00382903497034, BD MultiCheck CD4 Low Ctrl Vial UDI D
• 00382903497027: Multi-Check Control 5X2.5mL US-IVD DI 00382903497027, BD MultiCheck Control Vial UDI DI 00382903
• 00382903497010: Multi-Check Control 2X2.5mL US-IVD DI 00382903497010, BD MultiCheck Control Vial UDI DI 00382903
• 00382903497003: Multi-Check Control 1X2.5mL US-IVD