Dayspring SW 005

GUDID 00850012532613

Dayspring Mobile Application

Koya Medical, Inc.

Wearable sequential venous compression system

• Primary Device ID: 00850012532613
• NIH Device Record Key: 16ca4cb4-2301-4836-af71-03d761d97629
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dayspring
• Version Model Number: SW 005
• Catalog Number: SW 005
• Company DUNS: 100673310
• Company Name: Koya Medical, Inc.
• Device Count: 1
• DM Exempt: true
• 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: false
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(415)209-5035
• Email: clee@koyamedical.com
• Phone: +1(415)209-5035
• Email: clee@koyamedical.com
• Phone: +1(415)209-5035
• Email: clee@koyamedical.com
• Phone: +1(415)209-5035
• Email: clee@koyamedical.com
• Phone: +1(415)209-5035
• Email: clee@koyamedical.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850012532613 [Primary]

FDA Product Code

• JOW: SLEEVE, LIMB, COMPRESSIBLE

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: 2022-05-24
• Device Publish Date: 2022-05-16

On-Brand Devices [Dayspring]

• 00850012532651: CONTROLLER, DAYSPRING, LITE
• 00850012532644: LOWER LEG GARMENT, DAYSPRING
• 00850012532637: LEG GARMENT, DAYSPRING, LONG
• 00850012532620: LEG GARMENT, DAYSPRING, STANDARD
• 00850012532613: Dayspring Mobile Application