Koya Medical F-0100-12

GUDID 00850012532231

Dayspring Wearable Device - Short Arm Garment, X-Large Arm Liner, Large Gauntlet, Dayspring Controller, and Dayspring Charger

Koya Medical, Inc.

Wearable sequential venous compression system

• Primary Device ID: 00850012532231
• NIH Device Record Key: 067632f6-4b3d-45e4-b0cf-95be7655fb62
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Koya Medical
• Version Model Number: F-0100-12
• Catalog Number: F-0100-12
• 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: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• 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(925)338-5193
• Email: susan@koyainc.com
• Phone: +1(925)338-5193
• Email: susan@koyainc.com
• Phone: +1(925)338-5193
• Email: susan@koyainc.com
• Phone: +1(925)338-5193
• Email: susan@koyainc.com
• Phone: +1(925)338-5193
• Email: susan@koyainc.com
• Phone: +1(925)338-5193
• Email: susan@koyainc.com
• Phone: +1(925)338-5193
• Email: susan@koyainc.com
• Phone: +1(925)338-5193
• Email: susan@koyainc.com
• Phone: +1(925)338-5193
• Email: susan@koyainc.com
• Phone: +1(925)338-5193
• Email: susan@koyainc.com
• Phone: +1(925)338-5193
• Email: susan@koyainc.com
• Phone: +1(925)338-5193
• Email: susan@koyainc.com
• Phone: +1(925)338-5193
• Email: susan@koyainc.com
• Phone: +1(925)338-5193
• Email: susan@koyainc.com
• Phone: +1(925)338-5193
• Email: susan@koyainc.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
• 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
• 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	00850012532231 [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: 2020-12-23
• Device Publish Date: 2020-12-15

On-Brand Devices [Koya Medical]

• 00850012532606: Arm Liner, X-Large
• 00850012532590: Dayspring Wearable Device - Medium Arm Garment, Large Arm Liner, Medium Gauntlet, Dayspring Con
• 00850012532583: Dayspring Wearable Device - Long Arm Garment, X-Large Arm Liner, X-Large Gauntlet, Dayspring Co
• 00850012532576: Dayspring Wearable Device - Long Arm Garment, Large Arm Liner, X-Large Gauntlet, Dayspring Cont
• 00850012532569: Dayspring Wearable Device - Long Arm Garment, Medium Arm Liner, X-Large Gauntlet, Dayspring Con
• 00850012532552: Dayspring Wearable Device - Long Arm Garment, Small Arm Liner, X-Large Gauntlet, Dayspring Cont
• 00850012532545: Dayspring Wearable Device - Long Arm Garment, X-Large Arm Liner, Large Gauntlet, Dayspring Cont
• 00850012532538: Dayspring Wearable Device - Long Arm Garment, Large Arm Liner, Large Gauntlet, Dayspring Contro
• 00850012532521: Dayspring Wearable Device - Long Arm Garment, Medium Arm Liner, Large Gauntlet, Dayspring Contr
• 00850012532514: Dayspring Wearable Device - Long Arm Garment, Small Arm Liner, Large Gauntlet, Dayspring Contro
• 00850012532507: Dayspring Wearable Device - Long Arm Garment, Large Arm Liner, Medium Gauntlet, Dayspring Contr
• 00850012532491: Dayspring Wearable Device - Long Arm Garment, X-Large Arm Liner, Medium Gauntlet, Dayspring Con
• 00850012532484: Dayspring Wearable Device - Long Arm Garment, Small Arm Liner, Medium Gauntlet, Dayspring Contr
• 00850012532477: Dayspring Wearable Device - Long Arm Garment, Medium Arm Liner, Medium Gauntlet, Dayspring Cont
• 00850012532460: Dayspring Wearable Device - Long Arm Garment, X-Large Arm Liner, Small Gauntlet, Dayspring Cont
• 00850012532453: Dayspring Wearable Device - Long Arm Garment, Large Arm Liner, Small Gauntlet, Dayspring Contro
• 00850012532446: Dayspring Wearable Device - Long Arm Garment, Medium Arm Liner, Small Gauntlet, Dayspring Contr
• 00850012532439: Dayspring Wearable Device - Long Arm Garment, Small Arm Liner, Small Gauntlet, Dayspring Contro
• 00850012532422: Dayspring Wearable Device - Medium Arm Garment, Large Arm Liner, X- Large Gauntlet, Dayspring C
• 00850012532415: Dayspring Wearable Device - Medium Arm Garment, X-Large Arm Liner, X- Large Gauntlet, Dayspring
• 00850012532408: Dayspring Wearable Device - Medium Arm Garment, Medium Arm Liner, X- Large Gauntlet, Dayspring
• 00850012532392: Dayspring Wearable Device - Medium Arm Garment, Small Arm Liner, X- Large Gauntlet, Dayspring C
• 00850012532385: Dayspring Wearable Device - Medium Arm Garment, X-Large Arm Liner, Large Gauntlet, Dayspring Co
• 00850012532378: Dayspring Wearable Device - Medium Arm Garment, Large Arm Liner, Large Gauntlet, Dayspring Cont
• 00850012532361: Dayspring Wearable Device - Medium Arm Garment, Medium Arm Liner, Large Gauntlet, Dayspring Con
• 00850012532354: Dayspring Wearable Device - Medium Arm Garment, Small Arm Liner, Large Gauntlet, Dayspring Cont
• 00850012532347: Dayspring Wearable Device - Medium Arm Garment, X- Large Arm Liner, Medium Gauntlet, Dayspring
• 00850012532330: Dayspring Wearable Device - Medium Arm Garment, Medium Arm Liner, Medium Gauntlet, Dayspring Co
• 00850012532323: Dayspring Wearable Device - Medium Arm Garment, Small Arm Liner, Medium Gauntlet, Dayspring Con
• 00850012532316: Dayspring Wearable Device - Medium Arm Garment, X-Large Arm Liner, Small Gauntlet, Dayspring Co
• 00850012532309: Dayspring Wearable Device - Medium Arm Garment, Large Arm Liner, Small Gauntlet, Dayspring Cont
• 00850012532293: Dayspring Wearable Device - Medium Arm Garment, Medium Arm Liner, Small Gauntlet, Dayspring Con
• 00850012532286: Dayspring Wearable Device - Medium Arm Garment, Small Arm Liner, Small Gauntlet, Dayspring Cont
• 00850012532279: Dayspring Wearable Device - Short Arm Garment, X-Large Arm Liner, X-Large Gauntlet, Dayspring C
• 00850012532262: Dayspring Wearable Device - Short Arm Garment, Large Arm Liner, X-Large Gauntlet, Dayspring Con
• 00850012532255: Dayspring Wearable Device - Short Arm Garment, Medium Arm Liner, X-Large Gauntlet, Dayspring Co
• 00850012532248: Dayspring Wearable Device - Short Arm Garment, Small Arm Liner, X-Large Gauntlet, Dayspring Con
• 00850012532231: Dayspring Wearable Device - Short Arm Garment, X-Large Arm Liner, Large Gauntlet, Dayspring Con
• 00850012532224: Dayspring Wearable Device - Short Arm Garment, Large Arm Liner, Large Gauntlet, Dayspring Contr
• 00850012532217: Dayspring Wearable Device - Short Arm Garment, Medium Arm Liner, Large Gauntlet, Dayspring Cont
• 00850012532200: Dayspring Wearable Device - Short Arm Garment, Small Arm Liner, Large Gauntlet, Dayspring Contr
• 00850012532194: Dayspring Wearable Device - Short Arm Garment, X-Large Arm Liner, Medium Gauntlet, Dayspring Co
• 00850012532187: Dayspring Wearable Device - Short Arm Garment, Large Arm Liner, Medium Gauntlet, Dayspring Cont
• 00850012532170: Dayspring Wearable Device - Short Arm Garment, Medium Arm Liner, Medium Gauntlet, Dayspring Con
• 00850012532163: Dayspring Wearable Device - Short Arm Garment, Small Arm Liner, Medium Gauntlet, Dayspring Cont
• 00850012532156: Dayspring Wearable Device - Short Arm Garment, X-Large Arm Liner, Small Gauntlet, Dayspring Con
• 00850012532149: Dayspring Wearable Device - Short Arm Garment, Large Arm Liner, Small Gauntlet, Dayspring Contr
• 00850012532132: Dayspring Wearable Device - Short Arm Garment, Medium Arm Liner, Small Gauntlet, Dayspring Cont
• 00850012532125: Dayspring Wearable Device - Short Arm Garment, Small Arm Liner, Small Gauntlet, Dayspring Contr
• 00850012532118: Dayspring Charger