Venoscope NT01

GUDID B853NT010

Handheld battery operated transilluminator used for locating veins for IV therapy and blood draws in small neonate patients.

VENOSCOPE, LLC

Skin transilluminator, battery-powered

• Primary Device ID: B853NT010
• NIH Device Record Key: cd0b5a47-0d90-4737-b943-c1c2df068e4c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Venoscope
• Version Model Number: NT01
• Catalog Number: NT01
• Company DUNS: 612726596
• Company Name: VENOSCOPE, LLC
• 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: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 800-284-7655
• Email: info@venoscope.com

Device Dimensions

• Width: 2.25 Inch

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B853NT010 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K941035

FDA Product Code

• HJN: Transilluminator, Battery-Powered

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: 2020-03-23
• Device Publish Date: 2020-03-13

On-Brand Devices [Venoscope]

• B853VT030: Handheld battery operated transilluminator used to locate veins for IV therapy or blood draws in
• B853NT010: Handheld battery operated transilluminator used for locating veins for IV therapy and blood draw