FDA.reportPublic FDA data

hypodermic syringes(safety needle)

Primary DI
06949236205077
Brand
hypodermic syringes(safety needle)
Company
Berpu Medical Technology Co.,Ltd
Model
1ml 25G×25mmTW
Published
2021-01-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FMFSyringe, Piston

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMFSyringe, PistonGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06949236205077PackageGS1100In Commercial Distribution
06949236205084PackageGS112In Commercial Distribution
06949236205060PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06949236205077069492362050776949236205077
06949236205084069492362050846949236205084
06949236205060069492362050606949236205060

GMDN Terms#

Term, Definition table
TermDefinition
Metered-delivery hypodermic syringeA sterile device consisting of a graduated barrel (cylinder) with plunger intended to be used to deliver (inject) or withdraw an accurate metered dose of a fluid to/from the body. The application of the content of this device may be in conjunction with an injector device (transcutaneous delivery) or through the traditional use of a needle (subcutaneous delivery). It may allow for retraction of an attached needle (safety syringe); the needle is not included. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
529239746
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06949236203493safety hypodermic needles"18Gx1""(1.2x25mm)"2022-11-21
06949236203509safety hypodermic needles"18Gx1 1/2""(1.2x38mm)"2022-11-21
06949236203516safety hypodermic needles"20Gx1""(0.9x25mm)"2022-11-21
06949236203523safety hypodermic needles"21Gx1""(0.8x25mm)"2022-11-21
06949236203530safety hypodermic needles"21Gx1 1/2""(0.8x38mm)"2022-11-21
06949236203547safety hypodermic needles"22Gx1""(0.7x25mm)"2022-11-21
06949236203554safety hypodermic needles"22Gx1 1/2""(0.7x38mm)"2022-11-21
06949236203561safety hypodermic needles"23Gx1""(0.6x25mm)"2022-11-21
06949236203578safety hypodermic needles"25Gx5/8""(0.5x16mm)"2022-11-21
06949236203585safety hypodermic needles"25Gx1""(0.5x25mm)"2022-11-21
06949236203592safety hypodermic needles"27Gx1/2""(0.4x13mm)"2022-11-21
06949236203608safety hypodermic needles"30Gx1/2""(0.31x13mm)"2022-11-21
16949236203490safety hypodermic needles18Gx1"(1.2x25mm)2022-11-21
16949236203506safety hypodermic needles18Gx1 1/2"(1.2x38mm)2022-11-21
16949236203513safety hypodermic needles20Gx1"(0.9x25mm)2022-11-21
16949236203520safety hypodermic needles21Gx1"(0.8x25mm)2022-11-21
16949236203537safety hypodermic needles21Gx1 1/2"(0.8x38mm)2022-11-21
16949236203544safety hypodermic needles22Gx1"(0.7x25mm)2022-11-21
16949236203551safety hypodermic needles22Gx1 1/2"(0.7x38mm)2022-11-21
16949236203568safety hypodermic needles23Gx1"(0.6x25mm)2022-11-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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05391530753999polycarbonate syringesDMC MEDICAL LIMITEDFMF2026-10-01
05391530754408polycarbonate syringesDMC MEDICAL LIMITEDFMF2026-10-01
05391530754439polycarbonate syringesDMC MEDICAL LIMITEDFMF2026-10-01
05391530754750polycarbonate syringesDMC MEDICAL LIMITEDFMF2026-10-01
05391530754798polycarbonate syringesDMC MEDICAL LIMITEDFMF2026-10-01
05391530755351polycarbonate syringesDMC MEDICAL LIMITEDFMF2026-10-01
M99208012905P120LCH3Livaclean HealthCarelife (usa) Inc.FMF2026-09-30
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
10192253070804MonojectCardinal Health 200, LLCFMF2026-09-21
M992MTINS01291271MedThermalCarelife (usa) Inc.FMF2026-09-18
M992MTINS0331081MedThermalCarelife (usa) Inc.FMF2026-09-18
00850091070242CoreCareCORECARE PRODUCTS INC.FMF2026-09-04
00850091070372CoreCareCORECARE PRODUCTS INC.FMF2026-09-04
00850091070389CoreCareCORECARE PRODUCTS INC.FMF2026-09-04
00850091070396CoreCareCORECARE PRODUCTS INC.FMF2026-09-04