FDA.reportPublic FDA data

DANA Diabecare

Primary DI
08809220581045
Brand
DANA Diabecare
Company
SOOIL DEVELOPMENT CO.,LTD
Model
ⅡS Kits
Device description
DANA Diabecare ⅡS is external programmable syringe infusion pump used for the subcutaneous delivery of insulin for the treatment of diabetes mellitus.
Published
2016-10-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
LGZWarmer, Thermal, Infusion Fluid
MRZAccessories, Pump, Infusion

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LGZWarmer, Thermal, Infusion FluidGeneral Hospital2
MRZAccessories, Pump, InfusionGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K022317000
K063126000
K071418000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K022317000DANA DIABECARE II INSULIN PUMP & SUPERLINE-EASYRELEASE, SOFT-RELEASE-ST, & SOFT-RELEASE-R INFUSION SETSSooil Development Co., Ltd.2002-08-02LZG
K063126000DANA DIABECARE IISSooil Development Co., Ltd.2007-02-02LZG
K071418000DANA 3CC SYRINGE INSULIN RESERVOIRSooil Development Co., Ltd.2007-09-04MRZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809220581045PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809220581045088092205810458809220581045

GMDN Terms#

Term, Definition table
TermDefinition
Ambulatory insulin infusion pump reservoirAn insulin-filled receptacle (e.g., a cartridge similar to a syringe) intended to be used together with a body-worn insulin pump for the delivery of patient-controlled amounts of insulin to an ambulatory diabetic. This is a single-use device.

Regulatory Flags#

DUNS number
688006266
Device count
1
Kit
true
Combination product
true
Serial number
true
Manufacturing date on label
true

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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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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B286DWC243074TMBAVT1Dual Chamber Warming CabinetM.A.C. MEDICAL INC.LGZ2026-08-27
B286DWC243074TMBEL220C1Dual Chamber Warming CabinetM.A.C. MEDICAL INC.LGZ2026-08-27
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B286SWC242424GNB1Single CHAMBER WARMING CABINETM.A.C. MEDICAL INC.LGZ2026-08-21
B286DWC183074EG4BC1Dual Chamber Warming CabinetM.A.C. MEDICAL INC.LGZ2026-08-18
B286DWC183074EGMB220C1Dual Chamber Warming CabinetM.A.C. MEDICAL INC.LGZ2026-08-18
B286DWC183074T4BAVT1Dual Chamber Warming CabinetM.A.C. MEDICAL INC.LGZ2026-08-18
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