FDA.reportPublic FDA data

Cardinal Health

Primary DI
16971564467527
Brand
Cardinal Health
Company
Jiangsu Caina Medical Co.,Ltd
Model
1ml 30Gx5/16"
Catalog number
8881511310
Device description
Safety disposable insulin syringe is intended to inject U-100 insulin into the human body and aid in the prevention of accidental needle stick injuries.
Published
2023-07-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
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
K150758000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K150758000

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16971564467527PackageGS1100In Commercial Distribution
26971564467524PackageGS15In Commercial Distribution
06971564467520PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1697156446752716971564467527
2697156446752426971564467524
06971564467520069715644675206971564467520

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
544543513
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
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06971564461696ITLITL 100012026-09-30
06971564461702ITLITL 100022026-09-30
46971564464336CAINA"21Gx3/4"""2026-04-14
46971564464343CAINA1mL2026-04-14
06971564465021CAINA25501CA2552020-09-20
06971564465038CAINA25701CA2572020-09-20
06971564465045CAINA323501CA32352020-09-20
06971564465052CAINA325501CA32552020-09-20
06971564465069CAINA125501CA12552020-09-20
06971564465076CAINA123501CA12352020-09-20
06971564465083CAINA320501CA32052020-09-20
06971564465090CAINA322701CA32272020-09-20
06971564465106CAINA25G*5/8-01CA2532020-11-10
06971564465113CAINA1ml LL 30G*1/2-01CA13022020-11-10
06971564465120CAINA3ml LL 21G*1-01CA32152020-11-10
06971564465137CAINA3ml LL 22G*1-01CA32252020-11-10
06971564465144CAINA3ml LL 25G*5/8-01CA32532020-11-10
06971564465151CAINA325502CN32552020-12-01
06971564465175CAINA3ml LL 23G*1-02CN323102021-01-15
06971564465182CAINA3ml LL 23G*1.5-02CN323152021-01-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
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
10304040194284Henry ScheinHENRY SCHEIN, INC.FMF2026-10-05
10304040194291Henry ScheinHENRY SCHEIN, INC.FMF2026-10-05
10304040194307Henry ScheinHENRY SCHEIN, INC.FMF2026-10-05
10304040194314Henry ScheinHENRY SCHEIN, INC.FMF2026-10-05
05391530753982polycarbonate syringesDMC MEDICAL LIMITEDFMF2026-10-01
05391530753999polycarbonate syringesDMC MEDICAL LIMITEDFMF2026-10-01
05391530754408polycarbonate syringesDMC MEDICAL LIMITEDFMF2026-10-01