firefly ST2US25

GUDID 05060294771654

firefly T-2 carton of 25 pouches, each containing 2x firefly devices

FIRSTKIND LTD

Physical therapy transcutaneous neuromuscular electrical stimulation system

• Primary Device ID: 05060294771654
• NIH Device Record Key: 7a67144d-cd0d-4e73-843c-86cc128e8546
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: firefly
• Version Model Number: T-2
• Catalog Number: ST2US25
• Company DUNS: 216603021
• Company Name: FIRSTKIND LTD
• Device Count: 50
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	05060294771654 [Unit of Use]
GS1	05060294771661 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201131

FDA Product Code

• NGX: Stimulator, Muscle, Powered, For Muscle Conditioning

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: 2020-07-14
• Device Publish Date: 2020-07-06

On-Brand Devices [firefly]

• 05060294770459: T-1
• 05060294771654: firefly T-2 carton of 25 pouches, each containing 2x firefly devices
• 05060294770107: Knee Strap