FDA.reportPublic FDA data

Feel Ject(FIS-212, U-100, 1.0cc, 30G x 8mm)

Primary DI
08800045105478
Brand
Feel Ject(FIS-212, U-100, 1.0cc, 30G x 8mm)
Company
Feel Tech Bio Co., Ltd.
Model
FIS-212
Published
2026-02-06
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
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
08800045105478PackageGS1100In Commercial Distribution
08800045107403PackageGS13000In Commercial Distribution
08800045105461PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800045105478088000451054788800045105478
08800045107403088000451074038800045107403
08800045105461088000451054618800045105461

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
694632098
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
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
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
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
00884450486955Merit Medical®Merit Medical Systems, Inc.FMF2026-07-25
10816336022275NC600300-ENFNEOCHILD, LLCFMF2026-07-23
10816336022282NC602000-ENFNEOCHILD, LLCFMF2026-07-23
10816336022442NC600100-ENFNEOCHILD, LLCFMF2026-07-23
00884450492888Merit Medical®Merit Medical Systems, Inc.FMF2026-07-22
10383017593015Ultra-Fine SAFETYEmbecta Medical II, LLCFMF2026-07-21
10383017593213Ultra-Fine SAFETYEmbecta Medical II, LLCFMF2026-07-21
10383017593411Ultra-Fine SAFETYEmbecta Medical II, LLCFMF2026-07-21
10383017593510Ultra-Fine SAFETYEmbecta Medical II, LLCFMF2026-07-21
10383017593718Ultra-Fine SAFETYEmbecta Medical II, LLCFMF2026-07-21
10383017844612Ultra-Fine SAFETYEmbecta Medical II, LLCFMF2026-07-21
10383017844711Ultra-Fine SAFETYEmbecta Medical II, LLCFMF2026-07-21
10383017844919Ultra-Fine SAFETYEmbecta Medical II, LLCFMF2026-07-21
18257200121076O-GENESISOrthofix US LLCFMF2026-07-17
18257200121083O-GENESISOrthofix US LLCFMF2026-07-17
05391530753944Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-03
05391530753951Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-03
05391530754217Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-03
05391530754620Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-03
05391530754699Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-03
05391530754941NuGen syringeDMC MEDICAL LIMITEDFMF2026-06-03
05391530754965NuGen syringeDMC MEDICAL LIMITEDFMF2026-06-03
05391530753968Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-02
05391530754088Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-02
05391530754194Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-02
05391530754224Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-02
05391530754231Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-02
05391530753456Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01
05391530753463Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01
05391530753487Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01