FDA.reportPublic FDA data

Feel Ject(FIS-019, U-100, 0.3cc, 32G x 8mm)

Primary DI
08800045101890
Brand
Feel Ject(FIS-019, U-100, 0.3cc, 32G x 8mm)
Company
Feel Tech Bio Co., Ltd.
Model
FIS-019
Published
2026-02-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
K070917000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K070917000FEEL-JECT INSULIN SYRINGEFeel Tech2007-06-20FMF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800045101906PackageGS1100In Commercial Distribution
08800045107373PackageGS13000In Commercial Distribution
08800045101890PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800045101906088000451019068800045101906
08800045107373088000451073738800045107373
08800045101890088000451018908800045101890

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.

Regulatory Flags#

DUNS number
694632098
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800045103061Feel Ject(FIS-054, U-100, 1.0cc, 31G x 6mm)FIS-0542026-07-29
08800045105164Feel Ject(FIS-202, U-100, 0.3 cc, 29G x 12.7mm)FIS-2022026-07-29
08800045105256Feel Ject(FIS-205, U-100, 0.3 cc, 31G x 8mm)FIS-2052026-07-29
08800045105492Feel Ject(FIS-213, U-100, 1.0cc, 31G x 8mm)FIS-2132026-07-29
08800045105614Feel Ject(FIS-217, U-100, 0.5 cc, 31G x 6mm)FIS-2172026-07-29
08800045102040Feel Ject(FIS-024, U-100, 0.5cc, 32G x 8mm)FIS-0242026-02-06
08800045102194Feel Ject(FIS-029, U-100, 1.0cc, 32G x 8mm)FIS-0292026-02-06
08800045102521Feel Ject(FIS-039, U-100, 0.3cc, 31G x 6mm)FIS-0392026-02-06
08800045105195Feel Ject(FIS-203, U-100, 0.3 cc, 30G x 12.7mm)FIS-2032026-02-06
08800045105225Feel Ject(FIS-204, U-100, 0.3cc, 30G x 8mm)FIS-2042026-02-06
08800045105461Feel Ject(FIS-212, U-100, 1.0cc, 30G x 8mm)FIS-2122026-02-06
08800045105645Feel Ject(FIS-2502, U-100, 0.5 cc, 30G x 8mm)FIS-25022026-02-06
08800045101906Feel Ject(FIS-019, U-100, 0.3cc, 32G x 8mm)FIS-0192026-02-06
08800045102057Feel Ject(FIS-024, U-100, 0.5cc, 32G x 8mm)FIS-0242026-02-06
08800045102200Feel Ject(FIS-029, U-100, 1.0cc, 32G x 8mm)FIS-0292026-02-06
08800045102538Feel Ject(FIS-039, U-100, 0.3cc, 31G x 6mm)FIS-0392026-02-06
08800045105201Feel Ject(FIS-203, U-100, 0.3 cc, 30G x 12.7mm)FIS-2032026-02-06
08800045105232Feel Ject(FIS-204, U-100, 0.3cc, 30G x 8mm)FIS-2042026-02-06
08800045105478Feel Ject(FIS-212, U-100, 1.0cc, 30G x 8mm)FIS-2122026-02-06
08800045105652Feel Ject(FIS-2502, U-100, 0.5 cc, 30G x 8mm)FIS-25022026-02-06

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