FDA.reportPublic FDA data

RG3

Primary DI
G002RG30
Brand
RG3
Company
SHIFENG MEDICAL TECHNOLOGY CO.，LTD.
Model
RG3
Published
2022-07-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
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
K201634000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K201634000RG 3ml Medication CartridgeChengdu Shifeng Medical Technology Co., Ltd.2021-03-26MRZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G002RG30PrimaryHIBCC0

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
554525197
Device count
1
Lot or batch
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
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
G002UUSF2510SN0ShifengUUSF2510SN2021-02-14

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