FDA.reportPublic FDA data

UltiCare

Primary DI
10357515032192
Brand
UltiCare
Company
ULTIMED, INC.
Model
03219
Device description
"UltiCare Insulin Safety Syringes1mL, 29G x 1/2"" (.33mm x 12.7mm) U-1005 x 100ct Sterile Safety Syringes"
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
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
K103011000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K103011000ULTICARE SAFETY INSULIN SYRINGEUlti-Med Intl., Inc.2011-02-02MEG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20357515032199PackageGS1100In Commercial Distribution
30357515032196PackageGS15In Commercial Distribution
40357515032193PackageGS14In Commercial Distribution
10357515032192PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2035751503219920357515032199
3035751503219630357515032196
4035751503219340357515032193
1035751503219210357515032192

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
024723541
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
20357515755043UltiCare755042026-10-23
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06934841531291TKMDAnhui Tiankang Medical Technology Co., Ltd.FMF2026-10-23
20357515755043UltiCareULTIMED, INC.FMI2026-10-23
MHC182332552EasyTouchMHC MEDICAL PRODUCTS, LLCFMF2026-10-21
09347144013062Metier MedicalMETIER MEDICAL LTDFMF2026-10-19
09347144013123Metier MedicalMETIER MEDICAL LTDFMF2026-10-19
09347144010009Metier MedicalMETIER MEDICAL LTDMEG2026-10-17
09347144010030Metier MedicalMETIER MEDICAL LTDMEG2026-10-17
09347144010092Metier MedicalMETIER MEDICAL LTDMEG2026-10-17
09347144010122Metier MedicalMETIER MEDICAL LTDMEG2026-10-17
09347144015004Metier MedicalMETIER MEDICAL LTDFMF2026-10-12
09347144016186Metier MedicalMETIER MEDICAL LTDFMF2026-10-12
09347144016216Metier MedicalMETIER MEDICAL LTDFMF2026-10-12
16972857299337Pen Needles ClassicSandstone Medical (Suzhou) Inc.FMI2026-10-11
16972857299290Easydrip Readygard DuoSandstone Medical (Suzhou) Inc.FMI2026-10-09
16972857299306Easydrip ReadygardSandstone Medical (Suzhou) Inc.FMI2026-10-09
16972857299313Easydrip ReadygardSandstone Medical (Suzhou) Inc.FMI2026-10-09
20612479288496McKessonMCKESSON MEDICAL-SURGICAL INC.MEG2026-10-08
20612479288496McKessonMCKESSON MEDICAL-SURGICAL INC.FMF2026-10-08
20612479288526McKessonMCKESSON MEDICAL-SURGICAL INC.FMF2026-10-08
20612479288526McKessonMCKESSON MEDICAL-SURGICAL INC.MEG2026-10-08
20612479288557McKessonMCKESSON MEDICAL-SURGICAL INC.MEG2026-10-08
20612479288588McKessonMCKESSON MEDICAL-SURGICAL INC.MEG2026-10-08
00050428167243TRUEplusTRIVIDIA HEALTH, INC.FMI2026-10-07
00050428167267TRUEplusTRIVIDIA HEALTH, INC.FMI2026-10-07
10809160538913HalyardMEDICAL ACTION INDUSTRIES INC.FMI2026-09-24
16972857299252Pen NeedlesSandstone Medical (Suzhou) Inc.FMI2026-09-24
00850091070037CoreCareCorecare Products Inc.FMI2026-09-11
00850091070051CoreCareCorecare Products Inc.FMI2026-09-11
00850091070068CoreCareCorecare Products Inc.FMI2026-09-11
00850091070099CoreCareCorecare Products Inc.FMI2026-09-11