TwitchView™

Basic Information

• Brand Name: TwitchView™
• Primary DI: 00860298001048
• Version / Model: Charging Dock v1
• Company Name: BLINK DEVICE COMPANY
• Labeler DUNS: 105714027
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-09-05
• Public Version: 2
• Public Version Date: 2020-02-06
• Public Version Status: Update
• Public Device Record Key: e3d34ffc-5475-45fd-a6d5-4b7d6027e81a

Device Description

A pole-mounted wireless charging dock for the TwitchView™ Monitor that simplifies the clinical workflow by connecting directly to your facility’s electronic medical record or through middleware solutions.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• 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
KOI	Stimulator, Nerve, Peripheral, Electric	Anesthesiology	868.2775	2

GMDN Terms

Code	Name	Definition	Implantable	Status
17115	Noninvasive device battery charger	An electrically-powered device designed to supply an electrical charge, via a direct/wired or wireless connection, to the battery of a noninvasive device to recharge it for operation; it is not intended to receive data from and transmit data to other devices (i.e., not a transceiver). It is typically in the form of an electronic circuitry housing with a cable.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00860298001048	GS1

Premarket Submissions

Submission Number	Supplement Number
K172843	000