FDA.reportPublic FDA data

UltiCare

Primary DI
10357515032598
Brand
UltiCare
Company
ULTIMED, INC.
Model
03259
Device description
"UltiCare Insulin Safety Syringes0.5mL, 29G x 1/2"" (.33mm x 12.7mm) U1005 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
20357515032595PackageGS1100In Commercial Distribution
30357515032592PackageGS15In Commercial Distribution
40357515032599PackageGS14In Commercial Distribution
10357515032598PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2035751503259520357515032595
3035751503259230357515032592
4035751503259940357515032599
1035751503259810357515032598

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
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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