FDA.reportPublic FDA data

UltiCare

Primary DI
10357515192193
Brand
UltiCare
Company
ULTIMED, INC.
Model
0219PL
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

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

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMFSyringe, PistonGeneral Hospital2
FMINeedle, Hypodermic, Single LumenGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20357515092193PackageGS110In Commercial Distribution
10357515192193PrimaryGS10
00357515192196Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2035751509219320357515092193
1035751519219310357515192193
00357515192196003575151921963575151921960357515192196

GMDN Terms#

Term, Definition table
TermDefinition
Insulin syringe/needle, basicA sterile device consisting of a calibrated barrel (cylinder) with plunger intended to be used to administer an injection of insulin to a patient subcutaneously; a non-retractable needle is included, either attached or detached (usually capped for user protection). The syringe is typically made of plastic and silicone materials and will have plunger anti-sticking properties allowing smooth plunger movement. It can be used by healthcare personnel or patient, and will allow for the aspiration of the pharmaceutical from its container for direct administration to the patient or via an intravenous (IV) port, heparin lock, or saline lock. This is a single-use device.

Regulatory Flags#

DUNS number
024723541
Device count
10
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10357515710144UltiCare 6mm Pen Needle 5-pk995622019-10-10
10357515895438UltiCare 4mm Pen Needle 5pk995432019-10-11
20357515745426Simpli745422020-05-01
20357515745433Simpli745432020-05-01
20357515745525Simpli745522020-05-01
20357515745532Simpli745532020-05-01
20357515745624Simpli745622020-05-01
20357515745631Simpli745632020-05-01
20357515745822Simpli745822020-05-01
20357515745839Simpli745832020-05-01
20357515710158UltiCare710152019-04-30
20357515095453UltiCare095452016-09-24
20357515095651UltiCare095652016-09-24
20357515095859UltiCare095852016-09-24
20357515710004UltiCare710002016-09-24
20357515710011UltiCare710012016-09-24
20357515710028UltiCare710022016-09-24
20357515710035UltiCare710032016-09-24
20357515710042UltiCare710042016-09-24
20357515710059UltiCare710052016-09-24

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08800045105256Feel Ject(FIS-205, U-100, 0.3 cc, 31G x 8mm)Feel Tech Bio Co., Ltd.FMF2026-07-29
08800045105492Feel Ject(FIS-213, U-100, 1.0cc, 31G x 8mm)Feel Tech Bio Co., Ltd.FMF2026-07-29
08800045105614Feel Ject(FIS-217, U-100, 0.5 cc, 31G x 6mm)Feel Tech Bio Co., Ltd.FMF2026-07-29
10801902215175ARROWTELEFLEX INCORPORATEDFMI2026-07-29
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10816336022282NC602000-ENFNEOCHILD, LLCFMF2026-07-23
10816336022442NC600100-ENFNEOCHILD, LLCFMF2026-07-23
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10383017844919Ultra-Fine SAFETYEmbecta Medical II, LLCFMF2026-07-21
18257200121076O-GENESISOrthofix US LLCFMF2026-07-17
18257200121083O-GENESISOrthofix US LLCFMF2026-07-17
10192253005127MonojectCardinal Health 200, LLCFMI2026-07-13
10192253005509MonojectCardinal Health 200, LLCFMI2026-07-13
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00810011730816QikDiagTianjin Huahong Technology Co., Ltd.FMI2026-07-10
16972857297784Easydrip Glider5 Classic Pro Pen NeedlesSandstone Medical (Suzhou) Inc.FMI2026-07-09
16972857297791Easydrip PentaGlider Plus Pro Pen NeedlesSandstone Medical (Suzhou) Inc.FMI2026-07-09