FDA.reportPublic FDA data

Koya Medical

Primary DI
00850012532200
Brand
Koya Medical
Company
Koya Medical, Inc.
Model
F-0100-09
Catalog number
F-0100-09
Device description
KIT, DAYSPRING, F-0100-09
Published
2020-12-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JOWSLEEVE, LIMB, COMPRESSIBLE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JOWSleeve, Limb, CompressibleCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850012532200PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850012532200008500125322008500125322000850012532200

GMDN Terms#

Term, Definition table
TermDefinition
Wearable sequential venous compression systemA 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-20 Degrees Celsius60 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(925)338-5193susan@koyainc.com
+1(415)209-5035connor@koyamedical.com
+1(415)209-5035clee@koyamedical.com

Regulatory Flags#

DUNS number
100673310
Device count
1
DM exempt
true
Premarket exempt
true
Kit
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850012532743DAYSPRINGF-0040-032025-01-31
00850012532750DAYSPRINGF-0040-042025-01-31
00850012532767DAYSPRINGF-0040-052025-01-31
00850012532774DAYSPRINGF-0040-062025-01-31
00850012532781DAYSPRINGF-0040-072025-01-31
00850012532798DAYSPRINGF-0040-082025-01-31
00850012532705DAYSPRINGF-0010-072025-01-31
00850012532712DAYSPRINGF-0010-082025-01-31
00850012532729DAYSPRINGF-0010-092025-01-31
00850012532736DAYSPRINGF-0050-022025-01-31
00850012532675DAYSPRING ARM GARMENTF-0010-042023-09-20
00850012532682DAYSPRING ARM GARMENTF-0010-052023-09-20
00850012532699DAYSPRING ARM GARMENTF-0010-062023-09-20
00850012532057Koya MedicalF-0020-02F-0020-022020-12-15
00850012532613DayspringSW 005SW 0052022-05-16
00850012532620DAYSPRINGF-0040-01F-0040-012022-05-16
00850012532637DAYSPRINGF-0040-02F-0040-022022-05-16
00850012532644DAYSPRINGF-0050-01F-0050-012022-05-16
00850012532651DAYSPRINGF-0085-01F-0085-012022-05-16
00850012532002Koya MedicalF-0010-01F-0010-012020-12-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10193489024500MEDLINEMEDLINE INDUSTRIES, INC.JOW2026-05-18
10193489024531MEDLINEMEDLINE INDUSTRIES, INC.JOW2026-05-18
04719893351026WellellWellell Inc.JOW2026-03-17
08809802648494DVT-SERIESDAESUNG MAREF CO.,LTD.JOW2026-02-09
08809802648500DVT-SERIESDAESUNG MAREF CO.,LTD.JOW2026-02-09
08809802646810DVT-2600DAESUNG MAREF CO.,LTD.JOW2025-12-19
08809802646858DVT-4000SDAESUNG MAREF CO.,LTD.JOW2025-12-19
10080196138302MEDLINEMEDLINE INDUSTRIES, INC.JOW2025-10-14
10193489097252MEDLINEMEDLINE INDUSTRIES, INC.JOW2025-10-13
10192253057775CARDINAL HEALTHCardinal Health 200, LLCJOW2025-05-07
10192253057782CARDINAL HEALTHCardinal Health 200, LLCJOW2025-05-07
10192253057799CARDINAL HEALTHCardinal Health 200, LLCJOW2025-05-07
10192253057805CARDINAL HEALTHCardinal Health 200, LLCJOW2025-05-07
10192253057812CARDINAL HEALTHCardinal Health 200, LLCJOW2025-05-07
10192253057829CARDINAL HEALTHCardinal Health 200, LLCJOW2025-05-07
10193489003154MEDLINE RENEWALMEDLINE INDUSTRIES, INC.JOW2025-04-17
10193489003161MEDLINE RENEWALMEDLINE INDUSTRIES, INC.JOW2025-03-21
10080196391974MEDLINE RENEWALMEDLINE INDUSTRIES, INC.JOW2025-03-18
10197344104543MEDLINEMEDLINE INDUSTRIES, INC.JOW2025-03-11
10192253057768CARDINAL HEALTHCardinal Health 200, LLCJOW2025-02-19
10080196385409MEDLINEMEDLINE INDUSTRIES, INC.JOW2025-01-02
10192253016123Kendall SCDCardinal Health 200, LLCJOW2024-12-16
10192253016130Kendall SCDCardinal Health 200, LLCJOW2024-12-16
10192253016185Kendall SCDCardinal Health 200, LLCJOW2024-12-16
10197344098415MEDLINEMEDLINE INDUSTRIES, INC.JOW2024-12-02
10197344006687MEDLINEMEDLINE INDUSTRIES, INC.JOW2024-11-22
10192253057737CARDINAL HEALTHCardinal Health 200, LLCJOW2024-10-02
10885380184895CARDINAL HEALTHCardinal Health 200, LLCJOW2024-07-25
10885380184901CARDINAL HEALTHCardinal Health 200, LLCJOW2024-07-25
10885380184918CARDINAL HEALTHCardinal Health 200, LLCJOW2024-07-25