Scope Buddy Plus Tubing

GUDID 40677964021983

24 Hour Tubing for FUJIFILM 700 Endoscopes

MEDIVATORS INC.

Luer/non-ISO80369-standardized linear connector, reusable

• Primary Device ID: 40677964021983
• NIH Device Record Key: 8c7d0fac-7859-40d1-8b4f-868c69f49baa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Scope Buddy Plus Tubing
• Version Model Number: 4002910
• Company DUNS: 068199363
• Company Name: MEDIVATORS INC.
• 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: true
• 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	40677964021976 [Primary]
GS1	40677964021983 [Package]; Contains: 40677964021976; Package: [30 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162128

FDA Product Code

• FEB: Accessories, Cleaning, For Endoscope

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: 2021-07-12
• Device Publish Date: 2021-07-02

On-Brand Devices [Scope Buddy Plus Tubing ]

• 00677964092046: SB-110-HU1016
• 00677964082993: SB-110-HU1015
• 00677964082986: SB-110-HU1012
• 00677964082979: SB-110-HU1011
• 00677964082962: SB-110-HU1008
• 00677964082955: SB-110-HU1010
• 00677964082948: SB-110-HU1009
• 00677964082924: SB-110-HU1007
• 40677964021983: 24 Hour Tubing for FUJIFILM 700 Endoscopes