FDA.reportPublic FDA data

Monoject

Primary DI
20192253064312
Brand
Monoject
Company
Cardinal Health 200, LLC
Model
8881613150
Catalog number
8881613150
Device description
Monoject™ 0.5 mL Insulin Syringe Permanent Needle 31G x 15/64'' (0.25 x 6 mm)
Published
2024-03-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FMFSyringe, piston

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMFSyringe, PistonGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K151949000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K151949000

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20192253064312PackageGS1100In Commercial Distribution
50192253064313PackageGS15In Commercial Distribution
10192253064315PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2019225306431220192253064312
5019225306431350192253064313
1019225306431510192253064315

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
Length6Millimeter
Needle Gauge31Gauge
Total Volume0.5Milliliter

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
961027315
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10192253069693Curity6309G6309G2026-10-29
10198956253209CARDINAL HEALTHSOTCGUPTRDSOTCGUPTRD2026-10-29
10198956323209CARDINAL HEALTHPGX4LTPREPGX4LTPRE2026-10-29
10198956359888CARDINAL HEALTHSOPOCHAWMCSOPOCHAWMC2026-10-29
10198956381759CARDINAL HEALTH34-6599D34-6599D2026-10-29
10198956423534CARDINAL HEALTHSAN11PD10BSAN11PD10B2026-10-29
10198956428195CARDINAL HEALTHPOV2CHCPUPOV2CHCPU2026-10-29
10198956435292CARDINAL HEALTH03-6720C03-6720C2026-10-29
10198956468184CARDINAL HEALTHSNE7CLMNHMSNE7CLMNHM2026-10-29
10198956485372CARDINAL HEALTHSMA23GLNIGSMA23GLNIG2026-10-29
10198956496101CARDINAL HEALTHSMA4EDCBDCSMA4EDCBDC2026-10-29
10198956503519CARDINAL HEALTHSBA4LGLGRFSBA4LGLGRF2026-10-29
10198956504745CARDINAL HEALTHSCV3MLVCVBSCV3MLVCVB2026-10-29
10198956513310CARDINAL HEALTHSOP23SACACSOP23SACAC2026-10-29
10198956517240CARDINAL HEALTHSOP31KAOSXSOP31KAOSX2026-10-29
10198956521032CARDINAL HEALTHSENCGTACPCSENCGTACPC2026-10-29
10198956531932CARDINAL HEALTHSBA8CBPSPBSBA8CBPSPB2026-10-29
10198956533592CARDINAL HEALTHSAN42PMTMPSAN42PMTMP2026-10-29
10198956533653CARDINAL HEALTHSCV4AAAJHVSCV4AAAJHV2026-10-29
10198956534490CARDINAL HEALTHPU13CPAJEPU13CPAJE2026-10-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06934841531291TKMDAnhui Tiankang Medical Technology Co., Ltd.FMF2026-10-23
MHC182332552EasyTouchMHC MEDICAL PRODUCTS, LLCFMF2026-10-21
09347144013062Metier MedicalMETIER MEDICAL LTDFMF2026-10-19
09347144013123Metier MedicalMETIER MEDICAL LTDFMF2026-10-19
09347144015004Metier MedicalMETIER MEDICAL LTDFMF2026-10-12
09347144016186Metier MedicalMETIER MEDICAL LTDFMF2026-10-12
09347144016216Metier MedicalMETIER MEDICAL LTDFMF2026-10-12
20612479288496McKessonMCKESSON MEDICAL-SURGICAL INC.FMF2026-10-08
20612479288526McKessonMCKESSON MEDICAL-SURGICAL INC.FMF2026-10-08
10304040193843Henry ScheinHENRY SCHEIN, INC.FMF2026-10-05
10304040193850Henry ScheinHENRY SCHEIN, INC.FMF2026-10-05
10304040193867Henry ScheinHENRY SCHEIN, INC.FMF2026-10-05
10304040193874Henry ScheinHENRY SCHEIN, INC.FMF2026-10-05
10304040193881Henry ScheinHENRY SCHEIN, INC.FMF2026-10-05
10304040193898Henry ScheinHENRY SCHEIN, INC.FMF2026-10-05
10304040194109Henry ScheinHENRY SCHEIN, INC.FMF2026-10-05
10304040194116Henry ScheinHENRY SCHEIN, INC.FMF2026-10-05
10304040194208Henry ScheinHENRY SCHEIN, INC.FMF2026-10-05
10304040194215Henry ScheinHENRY SCHEIN, INC.FMF2026-10-05
00850091070532CoreCareCorecare Products Inc.FMF2026-09-11
00850091070556CoreCareCorecare Products Inc.FMF2026-09-11
00850091070570CoreCareCorecare Products Inc.FMF2026-09-11
00850091070594CoreCareCorecare Products Inc.FMF2026-09-11
00850091070617CoreCareCorecare Products Inc.FMF2026-09-11
00850091070631CoreCareCorecare Products Inc.FMF2026-09-11
00850091070655CoreCareCorecare Products Inc.FMF2026-09-11
00850091070679CoreCareCorecare Products Inc.FMF2026-09-11
10816336022671NC603500-ENFNEOCHILD, LLCFMF2026-09-10
00850091070242CoreCareCorecare Products Inc.FMF2026-09-04
00850091070372CoreCareCorecare Products Inc.FMF2026-09-04