SPOT

GUDID 17290017272501

The SPOT device is intended to provide healthcare professionals with a tool to document, track, and monitor chronic wounds which will aid in wound care management.

HEALTHY.IO LTD

Wound management image-analysis software Wound management image-analysis software Wound management image-analysis software Wound management image-analysis software Wound management image-analysis software Wound management image-analysis software Wound management image-analysis software Wound management image-analysis software Wound management image-analysis software Wound management image-analysis software Wound management image-analysis software Wound management image-analysis software Wound management image-analysis software Wound management image-analysis software Wound management image-analysis software Wound management image-analysis software Wound management image-analysis software Wound management image-analysis software Wound management image-analysis software Wound management image-analysis software Wound management image-analysis software Wound management image-analysis software Wound management image-analysis software Wound management image-analysis software Wound management image-analysis software Wound management image-analysis software Wound management image-analysis software Wound management image-analysis software Wound management image-analysis software Wound management image-analysis software Wound management image-analysis software Wound management image-analysis software Wound management image-analysis software Wound management image-analysis software Wound management image-analysis software Wound management image-analysis software Wound management image-analysis software Wound management image-analysis software Wound management image-analysis software Wound management image-analysis software Wound management image-analysis software Wound management image-analysis software Wound management image-analysis software Wound management image-analysis software Wound management image-analysis software Wound management image-analysis software Wound management image-analysis software Wound management image-analysis software Wound management image-analysis software Wound management image-analysis software Wound management image-analysis software Wound management image-analysis software Wound management image-analysis software

• Primary Device ID: 17290017272501
• NIH Device Record Key: ede28fc0-be1a-4b5a-b428-f88fcdf01af4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SPOT
• Version Model Number: SPOT.EN.GEN
• Company DUNS: 600437232
• Company Name: HEALTHY.IO LTD
• Device Count: 50
• 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: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between 10 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 27 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290017272504 [Unit of Use]
GS1	17290017272501 [Primary]
GS1	27290017272508 [Package]; Package: Box [10 Units]; In Commercial Distribution

FDA Product Code

• FXN: Tape, Camera, Surgical

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: 2020-09-02
• Device Publish Date: 2020-08-25

On-Brand Devices [SPOT]

• 17290017272501: The SPOT device is intended to provide healthcare professionals with a tool to document, track,
• 07290017272504: The SPOT device is intended to provide healthcare professionals with a tool to document, track,