SCOPE BUDDY PLUS TUBING

GUDID 00677964092046

MEDIVATORS INC.

Luer/non-ISO80369-standardized linear connector, reusable

• Primary Device ID: 00677964092046
• NIH Device Record Key: 2f99140f-b1a8-451a-9e6a-c80d6215f5a8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SCOPE BUDDY PLUS TUBING
• Version Model Number: SB-110-HU1016
• 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: true
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00677964092046 [Primary]
GS1	10677964092043 [Package]; Package: Box [30 Units]; In Commercial Distribution
GS1	20677964092040 [Package]; Contains: 10677964092043; Package: Case [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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-10-23
• Device Publish Date: 2019-06-04

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