FDA.reportPublic FDA data

Feel Ject(FIS-203, U-100, 0.3 cc, 30G x 12.7mm)

Primary DI
08800045105195
Brand
Feel Ject(FIS-203, U-100, 0.3 cc, 30G x 12.7mm)
Company
Feel Tech Bio Co., Ltd.
Model
FIS-203
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
08800045105201PackageGS1100In Commercial Distribution
08800045107359PackageGS13000In Commercial Distribution
08800045105195PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800045105201088000451052018800045105201
08800045107359088000451073598800045107359
08800045105195088000451051958800045105195

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
08800045101890Feel Ject(FIS-019, U-100, 0.3cc, 32G x 8mm)FIS-0192026-02-06
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
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
05391530754033Polycarbonate SyringeDMC MEDICAL LIMITEDFMF2026-09-27
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05391530754255polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-09-27
05391530754279polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-09-27
05391530754286polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-09-27
05391530754323polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-09-27
05391530754385polycarbonate syringesDMC MEDICAL LIMITEDFMF2026-09-27
05391530754415polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-09-27
05391530754477polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-09-27
05391530754484polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-09-27
05391530754651polycarbonate syringesDMC MEDICAL LIMITEDFMF2026-09-27
05391530754736polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-09-27
10192253070804MonojectCardinal Health 200, LLCFMF2026-09-21
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00850091070433CoreCareCORECARE PRODUCTS INC.FMF2026-09-04
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00193982458119INSTAFILLGLOBUS MEDICAL, INC.FMF2026-08-14