AccessGUDID - DEVICE: Koya Medical (00850012532514)

GUDID

Device Identifier (DI) Information

Brand Name: Koya Medical
Version or Model: F-0100-41
Commercial Distribution Status: In Commercial Distribution
Catalog Number: F-0100-41
Company Name: Koya Medical, Inc.

Primary DI Number: 00850012532514
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 100673310 *Terms of Use

Device Description: Dayspring Wearable Device - Long Arm Garment, Small Arm Liner, Large Gauntlet, Dayspring Controller, and Dayspring Charger

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
63558	Wearable sequential venous compression system	A noninvasive, electrically-powered, entirely patient-worn device assembly intended to improve venous and lymphatic return from the leg to help treat/prevent venous disorders/sequelae (e.g., swelling, pain, thrombosis). It consists of an electronic processor with a compressing mechanism (e.g., pump, contracting straps) intended to be strapped to the calf, which provides a continuous peristaltic wave motion, and used for prescribed periods of treatment. It is normally available [non-prescription] over-the-counter (OTC) for use in the home and/or for hospitalized/institutionalized patients.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JOW	SLEEVE, LIMB, COMPRESSIBLE

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between -20 and 60 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: d8c246b8-af39-49a1-882a-b955479dfb5d
Public Version Date: December 23, 2020
Public Version Number: 1
DI Record Publish Date: December 15, 2020