FDA.reportPublic FDA data

Monoject

Primary DI
20192253063278
Brand
Monoject
Company
Cardinal Health 200, LLC
Model
8881511201
Catalog number
8881511201
Device description
Tuberculin Safety Syringe with Needle
Published
2023-07-14
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
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
K192551000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K192551000

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20192253063278PackageGS1100In Commercial Distribution
50192253063279PackageGS15In Commercial Distribution
10192253063271PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2019225306327820192253063278
5019225306327950192253063279
1019225306327110192253063271

GMDN Terms#

Term, Definition table
TermDefinition
Insulin syringe/needle, safetyA sterile device consisting of a calibrated barrel (cylinder) with plunger intended to be used to administer an injection of insulin to a patient subcutaneously; it includes an attached needle with a safety mechanism, such as cylinder/flap shielding or retraction into the barrel or sleeve after use, providing protection against needle sticks and rendering the device unusable. The syringe is typically made of plastic and silicone materials and will have plunger anti-sticking properties (internally precoated with compatible substances) allowing smooth plunger movement. It can be used by healthcare personnel or patients.. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length0.5Inch
Needle Gauge28Gauge

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
20885380214377KendallCB2LCB2L2026-10-12
20885380214384KendallCB2LITECB2LITE2026-10-12
20885380214391KendallCB2XLCB2XL2026-10-12
20885380214407KendallCB3LCB3L2026-10-12
20885380214414KendallCB4LCB4L2026-10-12
10192253046397Kendall55535PAMD55535PAMD2023-09-27
10192253046762Kendall55588BAMD55588BAMD2023-10-09
10885380173691Curity6309G6309G2019-11-14
20192253039358Kerlix458845882025-03-19
20192253039365Kerlix50425042-2025-03-19
20192253039372Kerlix61206120-2025-03-19
20192253039396Kerlix507250722025-03-19
20192253039594Kerlix258525852025-03-19
20885380173490Curity2556G2556G2019-11-14
20885380173513Curity2835G2835G2019-11-14
20192253008347CARDINAL HEALTH5005005005002020-09-24
20192253016632Kendall222002A222002A-2024-02-28
20192253016830Kendall30710001307100012024-02-28
20192253017813KendallEF00149EF001492024-02-28
20885380130950MEDI-VAC65652-11965652-1192018-03-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
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.FMF2026-10-08
20612479288526McKessonMCKESSON MEDICAL-SURGICAL INC.FMF2026-10-08
00050428167243TRUEplusTRIVIDIA HEALTH, INC.FMI2026-10-07
00050428167267TRUEplusTRIVIDIA HEALTH, INC.FMI2026-10-07
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
10304040194222Henry ScheinHENRY SCHEIN, INC.FMF2026-10-05
10304040194239Henry ScheinHENRY SCHEIN, INC.FMF2026-10-05
10304040194246Henry ScheinHENRY SCHEIN, INC.FMF2026-10-05
10304040194253Henry ScheinHENRY SCHEIN, INC.FMF2026-10-05
10304040194260Henry ScheinHENRY SCHEIN, INC.FMF2026-10-05
10304040194277Henry ScheinHENRY SCHEIN, INC.FMF2026-10-05