FDA.reportPublic FDA data

2 Linking Screws

Primary DI
08809220581007
Brand
2 Linking Screws
Company
SOOIL DEVELOPMENT CO.,LTD
Model
Linking screw
Device description
The linking screw is an accessory for insulin pump use. The role is to change the rotary motion of the motor in insulin pump to rectilinear motion of plunger in insulin syringe reservoir.
Published
2018-05-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
LGZWarmer, Thermal, Infusion Fluid

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LGZWarmer, Thermal, Infusion FluidGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K063126000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K063126000DANA DIABECARE IISSooil Development Co., Ltd.2007-02-02LZG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809220581007PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809220581007088092205810078809220581007

GMDN Terms#

Term, Definition table
TermDefinition
Ambulatory insulin infusion pump, electronicA portable, battery-powered, electronic device designed to provide continuous or intermittent subcutaneous delivery of insulin to a patient with diabetes mellitus. It may be badge-like, designed to adhere to skin or clothing (e.g., with a pressure-sensitive adhesive), or worn in a case attached to the belt or carried in a pocket. It includes a reservoir (e.g., a cartridge similar to a syringe), a pumping mechanism, and an infusion-rate controller. The pump infuses microvolume pulses and/or bolus doses of insulin subcutaneously, typically into the abdomen, through a needle or catheter (not included).

Regulatory Flags#

DUNS number
688006266
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08809220580000SuperlineSU0012023-06-14
08809220580017SuperlineSU0022023-06-14
08809220580031SuperlineSU1012023-06-14
08809220580048SuperlineSU1022023-06-14
08809220584855DANA Diabecare 12023-06-09
18809220580434SuperlineSU0012023-06-14
08809220584862DANA Diabecare II2023-06-09
08809220580086Easy ReleaseSU3012016-08-11
08809220580178Easy ReleaseSU3022016-08-11
08809220580185Easy ReleaseSU3032016-08-11
08809220580192Easy ReleaseSU3112016-08-11
08809220580246Easy ReleaseSU3122016-08-11
08809220580253Easy ReleaseSU3132016-08-11
08809220580260Easy ReleaseSU3142016-08-11
08809220580277Easy ReleaseSU3152016-08-11
08809220580284Easy ReleaseSU3162016-08-11
08809220580406Soft-Release-STSR1022016-08-12
08809220580413Soft-Release-STSR1122016-08-12
08809220580789DANA DiabecareⅡS2016-08-24
088092205809942 Syringe Caps and 2 Battery CapsSyringe and battery cap2016-09-23

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