Koya Medical F-0100-23

GUDID 00850012532590

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

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 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 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 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 Wearable sequential venous compression system
Primary Device ID00850012532590
NIH Device Record Key6f3247fe-1eb2-473d-8350-b3a8f704f745
Commercial Distribution StatusIn Commercial Distribution
Brand NameKoya Medical
Version Model NumberF-0100-23
Catalog NumberF-0100-23
Company DUNS100673310
Company NameKoya Medical, Inc.
Device Count1
DM Exempttrue
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(925)338-5193
Emailsusan@koyainc.com
Phone+1(925)338-5193
Emailsusan@koyainc.com
Phone+1(925)338-5193
Emailsusan@koyainc.com
Phone+1(925)338-5193
Emailsusan@koyainc.com
Phone+1(925)338-5193
Emailsusan@koyainc.com
Phone+1(925)338-5193
Emailsusan@koyainc.com
Phone+1(925)338-5193
Emailsusan@koyainc.com
Phone+1(925)338-5193
Emailsusan@koyainc.com
Phone+1(925)338-5193
Emailsusan@koyainc.com
Phone+1(925)338-5193
Emailsusan@koyainc.com
Phone+1(925)338-5193
Emailsusan@koyainc.com
Phone+1(925)338-5193
Emailsusan@koyainc.com
Phone+1(925)338-5193
Emailsusan@koyainc.com
Phone+1(925)338-5193
Emailsusan@koyainc.com
Phone+1(925)338-5193
Emailsusan@koyainc.com
Phone+1(415)209-5035
Emailclee@koyamedical.com
Phone+1(415)209-5035
Emailclee@koyamedical.com
Phone+1(415)209-5035
Emailclee@koyamedical.com
Phone+1(415)209-5035
Emailclee@koyamedical.com
Phone+1(415)209-5035
Emailclee@koyamedical.com
Phone+1(415)209-5035
Emailclee@koyamedical.com

Operating and Storage Conditions

Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100850012532590 [Primary]

FDA Product Code

JOWSLEEVE, LIMB, COMPRESSIBLE

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-12-23
Device Publish Date2020-12-15

On-Brand Devices [Koya Medical]

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

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