FDA.reportPublic FDA data

Asmoh

Primary DI
10850060153164
Brand
Asmoh
Company
Asmoh USA Inc
Model
SYRINGE 5CC SAFETY NEEDLE 22G X 1 1/2", LUER LOCK
Device description
SYRINGE 5CC ASMOH SAFETY NEEDLE 22G X 1 1/2", LUER LOCK
Published
2024-03-18
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K222925000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K222925000Hypodermic Syringes & NeedleLifelong Meditech Private Limited2023-07-18FMF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850060153164PackageGS1100In Commercial Distribution
20850060153161PackageGS11200In Commercial Distribution
00850060153167PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085006015316410850060153164
2085006015316120850060153161
00850060153167008500601531678500601531670850060153167

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
125843506
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
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
00850060153068AsmohSYRINGE 3CC L/LOCK W/O NEEDLE2024-03-18
00850060153075AsmohSYRINGE 10CC L/LOCK W/O NEEDLE2024-03-18
00850060153082AsmohSYRINGE 20CC L/LOCK W/O NEEDLE2024-03-18
00850060153099AsmohSYRINGE 30CC L/LOCK W/O NEEDLE 2024-03-18
00850060153105AsmohSYRINGE 60CC L/LOCK W/O NEEDLE2024-03-18
00850060153112AsmohSYRINGE 5CC L/LOCK W/O NEEDLE 2024-03-18
00850060153129Asmoh"SYRINGE 1CC SAFETY NEEDLE 25G X 5/8"""2024-03-18
00850060153136Asmoh"SYRINGE 3CC SAFETY NEEDLE 22G X 1 1/2"", LUER LO2024-03-18
00850060153143Asmoh"SYRINGE 3CC SAFETY NEEDLE 22G X 1 1/2"", LUER LO2024-03-18
00850060153150Asmoh"SYRINGE 5CC SAFETY NEEDLE 21G X 1 1/2"", LUER LO2024-03-18
00850060153167Asmoh"SYRINGE 5CC SAFETY NEEDLE 22G X 1 1/2"", LUER LO2024-03-18
00850060153174Asmoh"SYRINGE 10CC SAFETY NEEDLE 21G X 1 1/2"", LUER LO2024-03-18
10850060153065AsmohSYRINGE 3CC L/LOCK W/O NEEDLE2024-03-18
10850060153072AsmohSYRINGE 10CC L/LOCK W/O NEEDLE2024-03-18
10850060153089AsmohSYRINGE 20CC L/LOCK W/O NEEDLE2024-03-18
10850060153096AsmohSYRINGE 30CC L/LOCK W/O NEEDLE 2024-03-18
10850060153102AsmohSYRINGE 60CC L/LOCK W/O NEEDLE2024-03-18
10850060153119AsmohSYRINGE 5CC L/LOCK W/O NEEDLE 2024-03-18
10850060153126AsmohSYRINGE 1CC SAFETY NEEDLE 25G X 5/8"2024-03-18
10850060153133AsmohSYRINGE 3CC SAFETY NEEDLE 22G X 1 1/2", LUER LOCK2024-03-18

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
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
00850091070402CoreCareCORECARE PRODUCTS INC.FMF2026-09-04
00850091070419CoreCareCORECARE PRODUCTS INC.FMF2026-09-04
00850091070426CoreCareCORECARE PRODUCTS INC.FMF2026-09-04
00850091070433CoreCareCORECARE PRODUCTS INC.FMF2026-09-04
06976523540238Sterile Insulin Syringes with needles for single useShandong Caremed Medical Products Co.,LtdFMF2026-08-26
06976523540245Sterile Insulin Syringes with needles for single useShandong Caremed Medical Products Co.,LtdFMF2026-08-26
06976523540252Sterile Insulin Syringes with needles for single useShandong Caremed Medical Products Co.,LtdFMF2026-08-26
00193982458119INSTAFILLGLOBUS MEDICAL, INC.FMF2026-08-14