Koya Medical - Dayspring Wearable Device - Short Arm Garment, - Koya Medical, Inc.

Duns Number:100673310

Device Description: Dayspring Wearable Device - Short Arm Garment, X-Large Arm Liner, Medium Gauntlet, Dayspr Dayspring Wearable Device - Short Arm Garment, X-Large Arm Liner, Medium Gauntlet, Dayspring Controller, and Dayspring Charger

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More Product Details

Catalog Number

F-0100-08

Brand Name

Koya Medical

Version/Model Number

F-0100-08

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

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)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

JOW

Product Code Name

SLEEVE, LIMB, COMPRESSIBLE

Device Record Status

Public Device Record Key

7c076791-7c5f-4818-b50e-577c7118f372

Public Version Date

December 23, 2020

Public Version Number

1

DI Record Publish Date

December 15, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"KOYA MEDICAL, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 66