FDA.reportPublic FDA data

DANA 3cc Syringe

Primary DI
08809220580765
Brand
DANA 3cc Syringe
Company
SOOIL DEVELOPMENT CO.,LTD
Model
DANA 3cc Syringe
Device description
DANA 3cc Syringe is an insulin reservoir for using insulin pump. It is installed into the SOOIL's insulin pump and connected to an infusion set in order to deliver insulin to the patients.
Published
2016-08-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
MRZAccessories, Pump, Infusion

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MRZAccessories, Pump, InfusionGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K071418000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K071418000DANA 3CC SYRINGE INSULIN RESERVOIRSooil Development Co., Ltd.2007-09-04MRZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809220580772PackageGS110In Commercial Distribution
08809220580956PackageGS110In Commercial Distribution
08809220580765PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809220580772088092205807728809220580772
08809220580956088092205809568809220580956
08809220580765088092205807658809220580765

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Needle Gauge26Gauge
Outer Diameter14.4Millimeter
Weight7.4Gram

Regulatory Flags#

DUNS number
688006266
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration 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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04046955739721SPACEB. BRAUN MEDICAL INC.MRZ2026-04-11
B553202291OTC0Health OptimizerWELLDOC, INC.MRZ2026-03-30
B553202292OTC0Health OptimizerWELLDOC, INC.MRZ2026-03-30
B553202293OTC0Health OptimizerWELLDOC, INC.MRZ2026-03-30
00085412718378Spectrum Wireless BatteryBAXTER HEALTHCARE CORPORATIONMRZ2025-10-10
00085412947914Spectrum Wireless BatteryBAXTER HEALTHCARE CORPORATIONMRZ2025-10-10
G001RG31RGChengdu Xinjin Shifeng Medical Apparatus & Instrument Co., Ltd.MRZ2025-06-27
00840365902096InvenioGri-Alleset, Inc.MRZ2025-03-12
10840365902093InvenioGRI Medical & Electronic Technology Co., Ltd.MRZ2025-03-12
07290109155296Sapphire PCA Lockbox 500mL Label EITAN MEDICAL LTDMRZ2024-11-29
15019517375244CADDICU MEDICAL, INC.MRZ2024-10-14
1729010915261250/100 Avoset PouchEITAN MEDICAL LTDMRZ2024-07-23
17290109152629Avoset Pouch ProEITAN MEDICAL LTDMRZ2024-07-23
2729010915261950/100 Avoset PouchEITAN MEDICAL LTDMRZ2024-07-23
27290109152626Avoset Pouch ProEITAN MEDICAL LTDMRZ2024-07-23
B553202191OTC0Health OptimizerWELLDOC, INC.MRZ2024-07-05
B553202192OTC0Health OptimizerWELLDOC, INC.MRZ2024-07-05
B553202193OTC0Health OptimizerWELLDOC, INC.MRZ2024-07-05
B553202091OTC0Health OptimizerWELLDOC, INC.MRZ2024-03-28
B553202092OTC0Health OptimizerWELLDOC, INC.MRZ2024-03-28
17290109151653PCA Lockbox 250 Strap and PouchEITAN MEDICAL LTDMRZ2024-03-19
27290109151650PCA Lockbox 250 Strap and PouchEITAN MEDICAL LTDMRZ2024-03-19
17290109154104Travel CaseEITAN MEDICAL LTDMRZ2024-03-03
27290109154101Travel CaseEITAN MEDICAL LTDMRZ2024-03-03
B553202093OTC0Health OptimizerWELLDOC, INC.MRZ2024-01-26
B553HLTHOPTIMIZER190Health OptimizerWELLDOC, INC.MRZ2024-01-26
B553HLTHOPTIMIZER180Health OptimizerWELLDOC, INC.MRZ2023-11-17
00850025535502UTC 3ml Medication CartridgeGilero, LLCMRZ2023-09-25
17290109154708Sapphire Power Supply - USEITAN MEDICAL LTDMRZ2023-09-05
27290109154705Sapphire Power Supply - USEITAN MEDICAL LTDMRZ2023-09-05