FDA.reportPublic FDA data

Shifeng

Primary DI
G002011070
Brand
Shifeng
Company
SHIFENG MEDICAL TECHNOLOGY CO.，LTD.
Model
01-107
Published
2021-02-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FMINeedle, Hypodermic, Single Lumen

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K132552000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K132552000U&U STERILE HYPODERMIC NEEDLEU&U Medical Technology Co, Ltd.2013-11-13FMI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G002011070PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Hypodermic needle, single-useA non-dedicated, sharp bevel-edged, hollow tubular device intended to be inserted beneath the skin of a patient while connected to a noninvasive device (e.g., syringe, secondary medication set) to administer and/or withdraw (aspirate) fluids/drugs; it may also be used for fluid/drug preparation. Some types are designed with a shielding mechanism (e.g., safety cap) for protection from sharp injuries. It is not specifically designed for blood collection or artery puncture, and does not have wings for fixation/placement (i.e., not a blood collection, intra-arterial, or venous butterfly needle). This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
554525197
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
G002100640EZ100642024-10-30
G002100620EZ100622024-10-28
G002HSB107119House Brand DentistryHSB-1071192023-09-25
G002HSB107110House brand HSB-1071102023-05-10
G002RG30RG3RG32022-07-22
G002100630Shifeng100632022-04-29
HSB107200House brandHSB-1072002022-04-17
HSB107114House brandHSB-1071142022-04-09
G002100170Shifeng100172021-09-26
G002100350Shifeng100352021-09-26
G002100360Shifeng100362021-09-26
G00210112251B0Shifeng1011-2251B2021-05-05
G002UU1L0UUUU1L2021-05-05
UUSF2251SN0ShifengUUSF2251SN2021-03-06
UUSF1LHN25100ShifengUUSF1LHN25102021-03-06
UUSF2231SN0ShifengUUSF2231SN2021-03-06
G002FUSF2510SN0FUTURE GENERATION MEDICALFUSF2510SN2021-02-27
G002UUSF1LHN23100ShifengUUSF1LHN23102021-02-27
G002UUSF2310SN0ShifengUUSF2310SN2021-02-27
G002UUSF1LL0ShifengUUSF1LL2021-02-14

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Primary DI, Brand, Company table
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00850091070334CoreCareCORECARE PRODUCTS INC.FMI2026-09-04
00850091070341CoreCareCORECARE PRODUCTS INC.FMI2026-09-04
00850091070365CoreCareCORECARE PRODUCTS INC.FMI2026-09-04
00850091070433CoreCareCORECARE PRODUCTS INC.FMI2026-09-04
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10192253005066MonojectCardinal Health 200, LLCFMI2026-07-31
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00810094578053Curaplex®BOUND TREE MEDICAL, LLCFMI2026-07-30
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