FDA.reportPublic FDA data

Asmoh

Primary DI
00850060153129
Brand
Asmoh
Company
Asmoh USA Inc
Model
"SYRINGE 1CC SAFETY NEEDLE 25G X 5/8"""
Device description
"SYRINGE 1CC ASMOH SAFETY NEEDLE 25G X 5/8"""
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
10850060153126PackageGS1100In Commercial Distribution
20850060153123PackageGS11200In Commercial Distribution
00850060153129PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085006015312610850060153126
2085006015312320850060153123
00850060153129008500601531298500601531290850060153129

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
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
10850060153140AsmohSYRINGE 3CC SAFETY NEEDLE 22G X 1 1/2", LUER LOCK2024-03-18

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