FDA.reportPublic FDA data

Syringe with Tip Cap (For Oral/Topical Use)

Primary DI
00338779565315
Brand
Syringe with Tip Cap (For Oral/Topical Use)
Company
Medisca Inc.
Model
5653-01
Catalog number
5653-01
Device description
Syringe, Clear, 3mL, w/Tip Cap (For Oral/Topical Use)
Published
2023-05-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
KYXDispenser, Liquid Medication

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KYXDispenser, Liquid MedicationGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00338779565315PrimaryGS10
10338779565312Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00338779565315003387795653153387795653150338779565315
1033877956531210338779565312

GMDN Terms#

Term, Definition table
TermDefinition
Oral/enteral medicine medicated administration kit, reusableA collection of devices with an included pharmaceutical intended to be used for the oral and/or enteral administration of an accurate dosage of the included medication. In addition to the pharmaceutical, it will include a dose measuring and/or dispensing device(s) such as a calibrated syringe, medicine cup, or spoon, and may include appropriate accessories (e.g., cap, bottle adaptor). This is a reusable device.

Regulatory Flags#

DUNS number
794301960
Device count
100
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00338779597415Medisca Safe-Sense5974-015974-012023-05-12
00338779597514Medisca Safe-Sense5975-015975-012023-05-12
00338779597613Medisca Safe-Sense5976-015976-012023-05-12
00038779578314Medisca Safe-Sense5783-015783-012023-02-23
00338779597316Medisca Safe-Sense 5973-015973-012023-05-12
00338779553114MEDISCA TRANSFER PIPETTE5531-015531-012023-09-18
00338779998410Vaginal Suppository Applicator9984-019984-012023-09-10
00338779998427Vaginal Suppository Applicator9984-029984-022023-09-10
00338779998434Vaginal Suppository Applicator9984-039984-032023-09-10
10338779998417Vaginal Suppository Applicator9984-019984-012023-09-10
10338779998424Vaginal Suppository Applicator9984-029984-022023-09-10
10338779998431Vaginal Suppository Applicator9984-039984-032023-09-10
00038779733515PreciseDose Dispenser7335-017335-012023-03-15
00038779733522PreciseDose Dispenser7335-027335-022023-03-15
00338779559314MD Ophthalmic Dropper Bottles5593-015593-012023-05-15
00338779559321MD Ophthalmic Dropper Bottles5593-025593-022023-05-15
00338779565216Syringe with Tip Cap (For Oral/Topical Use)5652-015652-012023-05-15
00338779565223Syringe with Tip Cap (For Oral/Topical Use)5652-025652-022023-05-15
00338779565322Syringe with Tip Cap (For Oral/Topical Use)5653-025653-022023-05-15
00338779565414Syringe with Tip Cap (For Oral/Topical Use)5654-015654-012023-05-15

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Primary DI, Brand, Company table
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