ViSi

Basic Information

• Brand Name: ViSi
• Primary DI: 10850733007183
• Version / Model: Thumb Tape (Qty 100)
• Catalog Number: 94-10007
• Company Name: Sotera Wireless, Inc.
• Labeler DUNS: 167142491
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2020-06-24
• Public Version: 3
• Public Version Date: 2022-06-10
• Public Version Status: Update
• Public Device Record Key: e228b26d-1372-492c-b2da-269df89ebc77

Device Description

Thumb Tape (Qty 100)

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DQA	Oximeter	Cardiovascular	870.2700	2

GMDN Terms

Code	Name	Definition	Implantable	Status
16866	Dressing-fixation skin adhesive tape, non-silicone	A long and narrow flexible band of non-silicone-based material (e.g., fabric, plastic, paper) coated on one or both sides with a pressure-sensitive adhesive, intended to non-invasively adhere to the skin surface to fix a dressing in place or attach objects (e.g., catheter, lamp); it might have hypoallergenic and/or waterproof properties. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	00850733007186	GS1
Primary	10850733007183	GS1

Premarket Submissions

Submission Number	Supplement Number
K152341	000