BD Viper™ PCR Extraction Reagent Trough with Piecring Tool 444087

GUDID 00382904440879

BD Viper™ PCR Extraction Reagent Trough with Piecring Tool

BECTON, DICKINSON AND COMPANY

Human papillomavirus (HPV) nucleic acid IVD, kit, nucleic acid technique (NAT)

• Primary Device ID: 00382904440879
• NIH Device Record Key: 1231a32a-835d-4dbe-a6b6-ee3d6eb96b24
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BD Viper™ PCR Extraction Reagent Trough with Piecring Tool
• Version Model Number: 444087
• Catalog Number: 444087
• Company DUNS: 122561087
• Company Name: BECTON, DICKINSON AND COMPANY
• Device Count: 12
• 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

Customer Support Contacts

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

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 33 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00382904440879 [Unit of Use]
GS1	30382904440870 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P160037

FDA Product Code

• MAQ: KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS

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: 2020-02-27
• Device Publish Date: 2020-02-19

Devices Manufactured by BECTON, DICKINSON AND COMPANY

• 50382903835893 - BD Nexiva™ Diffusics™ Closed IV Catheter System: 2025-09-17 NEXIVA DIFFUSICS w/MaxZero 18G X 1.75 IN
• 30382903835967 - BD Nexiva™ Diffusics™ Closed IV Catheter System: 2025-09-17 NEXIVA DIFFUSICS w/MaxZero 22G X 1.00 IN
• 30382902560921 - BD Veritor System for Rapid Detection of SARS-CoV-2: 2025-08-29 Veritor SARS-CoV2 assay Gen 2
• 30382902561386 - BD Veritor SARS-CoV-2 Control Swab Set: 2025-08-29 Veritor COVID Gen 2 control swab set
• 00382904413576 - BD ProbeTec™ Qx Collection Kit for Endocervical or Lesion Specimens: 2025-08-25 BD ProbeTec™ Qx Collection Kit for Endocervical or Lesion Specimens Contains: 100 each sterile polyester-tipped cleaning swab,
• 00382904413583 - Male Urethral Collection Kit for BD ProbeTec™ (CT/GC) Qx Amplified DNA Assays: 2025-08-25 Swab Male Urethral Specimen Collection
• 00382903059041 - BD SafetyGlide: 2025-08-07 SYRINGE 3ML LL W/NDL SFTYGLD 25X5/8 RB
• 00382903059058 - BD SafetyGlide: 2025-08-07 SYRINGE 3ML LL W/NDL SFTYGLD 23X1 RB