FDA.reportPublic FDA data

TopCare Insulin Syringe

Primary DI
00036800250819
Brand
TopCare Insulin Syringe
Company
Topco Associates, LLC
Model
103008
Device description
1cc 8mm 30G Insulin Syringe, Sterile, Single-Use, 100ct
Published
2016-09-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K062702000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K062702000ULTICARE DISPOSABLE SYRINGES AND NEEDLESUltimed, Inc.2006-11-29FMF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10036800250816PackageGS130Not in Commercial Distribution
00036800250819PrimaryGS10
10070030510715Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1003680025081610036800250816
00036800250819000368002508190368002508190036800250819
1007003051071510070030510715

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length8Millimeter
Needle Gauge30Gauge
Total Volume1Milliliter

Regulatory Flags#

DUNS number
072943876
Device count
100
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
00036800028326TopCare Health6 Days Sooner Pregnancy TestN/A2026-07-13
00036800028333TopCare Health6 Days Sooner Pregnancy TestN/A2026-07-13
00036800028340TopCare Health6 Days Sooner Pregnancy TestN/A2026-07-13
00036800028357TopCare Health6 Days Sooner Pregnancy TestN/A2026-07-13
00036800216587TopCare health0368002165872019-07-31
00036800216600TopCare health0368002166002019-07-31
00036800413634TopCare health0368004136342019-10-31
00036800024892TopCare health0368000248922026-02-05
10036800024899TopCare health0368000248922026-02-05
00036800024908TopCare health0368000249082026-01-30
10036800024905TopCare health0368000249082026-01-30
00036800022683TopCare HealthTOP4045V2TOP4045V22026-01-27
80368000226834TopCare HealthTOP4045V2TOP4045V22026-01-27
20036800367436TopCare Premium Blood Glucose Meter8000-071642016-09-24
00036800250789TopCare Insulin Syringe1029122016-10-04
00036800250826TopCare Insulin Syringe0331082016-09-24
20036800367443TopCare Premium Blood Glucose Test Strips8000-071582016-09-24
20036800422159TopCare Premium Blood Glucose Test Strips8000-104432016-09-24
00036800250796TopCare Insulin Syringe0330082016-09-24
00036800250802TopCare Insulin Syringe0530082016-09-24

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