RespoKare

GUDID 00840039200527

INNONIX TECHNOLOGIES LIMITED

Surgical/medical respirator, antimicrobial

• Primary Device ID: 00840039200527
• NIH Device Record Key: 24d17cb6-5655-4a7d-8bfc-643ba599f189
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RespoKare
• Version Model Number: 1110
• Company DUNS: 680118887
• Company Name: INNONIX TECHNOLOGIES LIMITED
• Device Count: 10
• 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: 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840039200015 [Primary]
GS1	00840039200527 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K101128

FDA Product Code

• OUK: Surgical Mask With Antimicrobial/Antiviral Agent

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: 2021-01-21
• Device Publish Date: 2021-01-13

On-Brand Devices [RespoKare]

• 00840039200213: 1103
• 00840039200527: 1110
• 00840039200558: RespoKare Anti-viral Mask
• 00840039200565: RespoKare Anti-viral Mask
• 00840039200640: The RespoKare Anti-viral Child Mask is a single use, disposable device that is intended to be wo