Automated Wound Measurements

GUDID 00860475000383

EPIC SYSTEMS CORPORATION

Wound management image-analysis software

• Primary Device ID: 00860475000383
• NIH Device Record Key: 5036c745-51ea-4a53-8ed3-a5e3d28690b3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Automated Wound Measurements
• Version Model Number: 1
• Company DUNS: 108299124
• Company Name: EPIC SYSTEMS CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• 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: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860475000383 [Primary]

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: 2025-02-11
• Device Publish Date: 2025-02-03

Devices Manufactured by EPIC SYSTEMS CORPORATION

• 00850053416002 - Blood Product Administration Module: 2025-02-11
• 00860475000383 - Automated Wound Measurements: 2025-02-11
• 00860475000383 - Automated Wound Measurements: 2025-02-11
• 00860475000345 - Blood Product Administration Module: 2023-06-27
• 00860475000314 - Blood Product Administration Module: 2020-11-10