DAYSPRING F-0040-02

GUDID 00850012532637

LEG GARMENT, DAYSPRING, LONG

Koya Medical, Inc.

Wearable sequential venous compression system Wearable sequential venous compression system Wearable sequential venous compression system Wearable sequential venous compression system Wearable sequential venous compression system

• Primary Device ID: 00850012532637
• NIH Device Record Key: a39b793f-8f7b-431c-81f5-f1fa606f887a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DAYSPRING
• Version Model Number: F-0040-02
• Catalog Number: F-0040-02
• 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: true
• Serial Number: true
• Manufacturing Date: true
• 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	00850012532637 [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