FDA.reportPublic FDA data

Asmoh

Primary DI
00850060153143
Brand
Asmoh
Company
Asmoh USA Inc
Model
"SYRINGE 3CC SAFETY NEEDLE 22G X 1 1/2"", LUER LO
Device description
"SYRINGE 3CC 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
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FMFSyringe, Piston
FMINeedle, Hypodermic, Single Lumen
MEGSyringe, Antistick

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMFSyringe, PistonGeneral Hospital2
FMINeedle, Hypodermic, Single LumenGeneral Hospital2
MEGSyringe, AntistickGeneral 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
10850060153140PackageGS1100In Commercial Distribution
20850060153147PackageGS11200In Commercial Distribution
00850060153143PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085006015314010850060153140
2085006015314720850060153147
00850060153143008500601531438500601531430850060153143

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.

Regulatory Flags#

DUNS number
125843506
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

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
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
10850060153140AsmohSYRINGE 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
05391530753944FD-1017NS - 1ml PC Syringe - White PlungerDMC MEDICAL LIMITEDFMF2026-06-03
05391530753951FD-1018NS - 1ml PC Syringe - Blue PlungerDMC MEDICAL LIMITEDFMF2026-06-03
05391530754217FD-1078NS 20ml PC Syringe - White Plunger - Saline PrintDMC MEDICAL LIMITEDFMF2026-06-03
05391530754620FD-1048NS 10ml PC Syringe Yellow Plunger LidocaineDMC MEDICAL LIMITEDFMF2026-06-03
05391530754699FD-1075NS 10ml PC Syringe Light Blue Plunger XylocaineDMC MEDICAL LIMITEDFMF2026-06-03
05391530754941FD-1180NS 3ml Nugen Syringe Red PlungeDMC MEDICAL LIMITEDFMF2026-06-03
05391530754965FD-1162NS 10ml Nugen Syringe Red PlungerDMC MEDICAL LIMITEDFMF2026-06-03
M6898250403050MEDIC ENHANCEMENT SETSafeguard US Operating, LLCFMI2026-06-03
05391530753968FD-1019NS - 1ml PC Syringe - Yellow PlungerDMC MEDICAL LIMITEDFMF2026-06-02
05391530754088FD-1021NS 3ml PC Syringe White PlungerDMC MEDICAL LIMITEDFMF2026-06-02
05391530754194FD-1034NS 20ml PC Syringe Red PlungerDMC MEDICAL LIMITEDFMF2026-06-02
05391530754224FD-1033NS 20ml PC Syringe - Yellow PlungerDMC MEDICAL LIMITEDFMF2026-06-02
05391530754231FD-1092NS 20ml PC Syringe Heparin Print - Red PlungerDMC MEDICAL LIMITEDFMF2026-06-02
05391530753456FD-1032NS - 20ml PC Syringe Blue PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753463FD-1031NS - 20ml PC Syringe White PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753487FD-1113NS - 10ml PC Syringe Contrast Dark Green PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753517FD-1051NS - 10ml PC Syringe Purple Plunger - Lidocaine PrintDMC MEDICAL LIMITEDFMF2026-06-01
05391530753524FD-1043NS - 10ml PC Syringe - Contrast - Yellow PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753531FD-1107NS - 30ml PC Syringe - Yellow PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753548FD-1026NS - 10ml PC Syringe - White PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753555FD-1158NS - 10ml PC Syringe - Heparin/Saline White PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753562FD-1049NS - 10ml PC Syringe - Lidocaine Print - Red PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753579FD-1029NS - 10ml PC Syringe Red PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753593FD-1054NS - 10ml PC Syringe - Nitro Print - Red PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753609FD-1039NS - 10ml PC Syringe - Heparin Print - Red PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753616FD-1071NS - 10ml PC Syringe - Purple PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753623FD-1028NS - 10ml PC Syringe - Yellow PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753647FD-1072NS - 10ml PC Syringe Dark Green PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753654FD-1030NS - 10ml PC Syringe - Light Green PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753661FD-1042NS - 10ml PC Syringe - Contrast Print - Light Blue PlungerDMC MEDICAL LIMITEDFMF2026-06-01