FDA.reportPublic FDA data

Terumo

Primary DI
06930197851915
Brand
Terumo
Company
Shanghai Kindly Enterprise Development Group Co.,Ltd.
Model
SENG - SS-01L
Device description
Disposable Syringe without Needle 1cc/ml
Published
2023-02-28
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
FMFSyringe, Piston
FMINeedle, Hypodermic, Single Lumen

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMFSyringe, PistonGeneral Hospital2
FMINeedle, Hypodermic, Single LumenGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K112057000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K112057000KDL SYRINGES AND NEEDLEShanghai Kindly Enterprise Dev. Group Co.,2011-12-14FMF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16930197851912PackageGS1100In Commercial Distribution
26930197851919PackageGS136In Commercial Distribution
06930197851915PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1693019785191216930197851912
2693019785191926930197851919
06930197851915069301978519156930197851915

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose syringe/needleA sterile device consisting of a calibrated barrel (cylinder) with plunger intended to be used for injection/withdrawal of fluids/gas (e.g., medication) to/from a medical device or the body (i.e., capable of both); a non-retractable needle is included, either attached or detached (usually capped for user protection). It is intended for various medical applications and is not dedicated to medication administration. The syringe is typically made of plastic and silicone materials and may have anti-stick plunger allowing smooth plunger movement, either manually or by a syringe pump. This is a single-use device.

Regulatory Flags#

DUNS number
530462431
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
16930197851738TerumoSENG-01L2516R2023-02-28
16930197851745TerumoSENG-01L2525R2023-02-28
16930197851752TerumoSENG-01L2713R2023-02-28
16930197851776TerumoSENG-03L2325R2023-02-28
16930197851783TerumoSENG-03L2516R2023-02-28
16930197851790TerumoSENG-03L2525R2023-02-28
16930197851806TerumoSENG-03L2538R2023-02-28
16930197851813TerumoSENG-1825R2023-02-28
16930197851820TerumoSENG-1838R2023-02-28
16930197851837TerumoSENG-2238R2023-02-28
16930197851844TerumoSENG-2325R2023-02-28
16930197851851TerumoSENG-2338R2023-02-28
16930197851868TerumoSENG-2516R2023-02-28
16930197851875TerumoSENG-2525R2023-02-28
16930197851882TerumoSENG-2538R2023-02-28
06930197851892TerumoSENG-2713R2023-02-28
06930197851908TerumoSENG-3013R2023-02-28
16930197851899TerumoSENG-2713R2023-02-28
16930197851905TerumoSENG-3013R2023-02-28
16930197851912TerumoSENG - SS-01L2023-02-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05391530754033Polycarbonate SyringeDMC MEDICAL LIMITEDFMF2026-09-27
05391530754057Polycarbonate SyringeDMC MEDICAL LIMITEDFMF2026-09-27
05391530754118Polycarbonate SyringeDMC MEDICAL LIMITEDFMF2026-09-27
05391530754149polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-09-27
05391530754170polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-09-27
05391530754255polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-09-27
05391530754279polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-09-27
05391530754286polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-09-27
05391530754323polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-09-27
05391530754385polycarbonate syringesDMC MEDICAL LIMITEDFMF2026-09-27
05391530754415polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-09-27
05391530754477polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-09-27
05391530754484polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-09-27
05391530754651polycarbonate syringesDMC MEDICAL LIMITEDFMF2026-09-27
05391530754736polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-09-27
10192253005059MonojectCardinal Health 200, LLCFMI2026-09-24
10809160538913HalyardMEDICAL ACTION INDUSTRIES INC.FMI2026-09-24
16972857299252REDOX SMART PAN Pen NeedleSandstone Medical (Suzhou) Inc.FMI2026-09-24
MHC18290272EasyTouchMHC MEDICAL PRODUCTS, LLCFMI2026-09-22
MHC18310472EasyTouchMHC MEDICAL PRODUCTS, LLCFMI2026-09-22
MHC18313672EasyTouchMHC MEDICAL PRODUCTS, LLCFMI2026-09-22
MHC18320872EasyTouchMHC MEDICAL PRODUCTS, LLCFMI2026-09-22
MHC18323672EasyTouchMHC MEDICAL PRODUCTS, LLCFMI2026-09-22
10192253070804MonojectCardinal Health 200, LLCFMF2026-09-21
M992MTINS01291271MedThermalCarelife (usa) Inc.FMF2026-09-18
M992MTINS0331081MedThermalCarelife (usa) Inc.FMF2026-09-18
00850091070013CoreCareCORECARE PRODUCTS INC.FMI2026-09-04
00850091070235CoreCareCORECARE PRODUCTS INC.FMI2026-09-04
00850091070242CoreCareCORECARE PRODUCTS INC.FMI2026-09-04
00850091070242CoreCareCORECARE PRODUCTS INC.FMF2026-09-04