FDA.reportPublic FDA data

Selfinject

Primary DI
08586015049637
Brand
Selfinject
Company
CHIRANA T.Injecta, a. s.
Model
U100 1ml 27G x 1/2”
Catalog number
AP03-19-00
Device description
1ml U100 insulin syringe with integrated needle 27G x 1/2” (0,4 x 12,7mm) in blister packaging, for single use.
Published
2025-10-02
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
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
K242434000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K242434000Insulin SyringesChirana T. Injecta2024-12-24FMF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08586015049644PackageGS1100In Commercial Distribution
48586015049642PackageGS12000In Commercial Distribution
08586015049637PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08586015049644085860150496448586015049644
4858601504964248586015049642
08586015049637085860150496378586015049637

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Needle Gauge27Gauge
Total Volume1Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius40 Degrees Celsius

Regulatory Flags#

DUNS number
495329266
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08586015044786CHIRAVAC"18G x 1"""CHBCN181002026-04-27
08586015044793CHIRAVAC"18G x 1 1/2"""CHBCN181122026-04-27
08586015044809CHIRAVAC"20G x 1"""CHBCN201002026-04-27
08586015044816CHIRAVAC"20G x 1 1/2"""CHBCN201122026-04-27
08586015044823CHIRAVAC"21G x 1"""CHBCN211002026-04-27
08586015044830CHIRAVAC"21G x 1 1/2"""CHBCN211122026-04-27
08586015044847CHIRAVAC"22G x 1"""CHBCN221002026-04-27
08586015044854CHIRAVAC"22G x 1 1/2"""CHBCN221122026-04-27
08586015044861CHIRAVAC"23G x 1"""CHBCN231002026-04-27
08586015044878CHIRAVAC"23G x 1 1/2"""CHBCN231122026-04-27
08586026571264SelfinjectU100 1ml 28G x 1/2”AP03-25-002025-10-02
08586026571288SelfinjectU100 1ml 28G x 5/16”AP03-24-002025-10-02
08586026571455SelfinjectU100 1ml 28G x 1/2” polybagAP03-25-00/S102025-10-03
08586026571479SelfinjectU100 1ml 28G x 5/16” polybagAP03-24-00/S102025-10-03
08586015049729SelfinjectU100 1ml 27G x 1/2” polybagAP03-19-00/S102025-10-03
08586015049743SelfinjectU100 1ml 29G x 1/2” polybagAP03-20-00/S102025-10-03
08586015049767SelfinjectU100 1ml 30G x 1/2” polybagAP03-21-00/S102025-10-03
08586026571417SelfinjectU100 1ml 27G x 5/16” polybagAP03-18-00/S102025-10-03
08586026571493SelfinjectU100 1ml 29G x 5/16” polybagAP03-26-00/S102025-10-03
08586026571516SelfinjectU100 1ml 30G x 5/16” polybagAP03-27-00/S102025-10-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08586015044786CHIRAVACCHIRANA T.Injecta, a. s.FMI2026-04-27
08586015044793CHIRAVACCHIRANA T.Injecta, a. s.FMI2026-04-27
08586015044809CHIRAVACCHIRANA T.Injecta, a. s.FMI2026-04-27
08586015044816CHIRAVACCHIRANA T.Injecta, a. s.FMI2026-04-27
08586015044823CHIRAVACCHIRANA T.Injecta, a. s.FMI2026-04-27
08586015044830CHIRAVACCHIRANA T.Injecta, a. s.FMI2026-04-27
08586015044847CHIRAVACCHIRANA T.Injecta, a. s.FMI2026-04-27
08586015044854CHIRAVACCHIRANA T.Injecta, a. s.FMI2026-04-27
08586015044861CHIRAVACCHIRANA T.Injecta, a. s.FMI2026-04-27
08586015044878CHIRAVACCHIRANA T.Injecta, a. s.FMI2026-04-27
08699207302028Set InjectSET MEDIKAL SANAYI VE TICARET ANONIM SIRKETIFMF2026-03-17
08699207305036Set InjectSET MEDIKAL SANAYI VE TICARET ANONIM SIRKETIFMF2026-03-17
08699207310030Set InjectSET MEDIKAL SANAYI VE TICARET ANONIM SIRKETIFMF2026-03-17
08699207311006Set InjectSET MEDIKAL SANAYI VE TICARET ANONIM SIRKETIFMF2026-03-17
08699207320022Set InjectSET MEDIKAL SANAYI VE TICARET ANONIM SIRKETIFMF2026-03-17
08699207350029Set InjectSET MEDIKAL SANAYI VE TICARET ANONIM SIRKETIFMF2026-03-17
08800045101890Feel Ject(FIS-019, U-100, 0.3cc, 32G x 8mm)Feel Tech Bio Co., Ltd.FMF2026-02-06
08800045102040Feel Ject(FIS-024, U-100, 0.5cc, 32G x 8mm)Feel Tech Bio Co., Ltd.FMF2026-02-06
08800045102194Feel Ject(FIS-029, U-100, 1.0cc, 32G x 8mm)Feel Tech Bio Co., Ltd.FMF2026-02-06
08800045102521Feel Ject(FIS-039, U-100, 0.3cc, 31G x 6mm)Feel Tech Bio Co., Ltd.FMF2026-02-06
08800045105195Feel Ject(FIS-203, U-100, 0.3 cc, 30G x 12.7mm)Feel Tech Bio Co., Ltd.FMF2026-02-06
08800045105225Feel Ject(FIS-204, U-100, 0.3cc, 30G x 8mm)Feel Tech Bio Co., Ltd.FMF2026-02-06
08800045105461Feel Ject(FIS-212, U-100, 1.0cc, 30G x 8mm)Feel Tech Bio Co., Ltd.FMF2026-02-06
08800045105645Feel Ject(FIS-2502, U-100, 0.5 cc, 30G x 8mm)Feel Tech Bio Co., Ltd.FMF2026-02-06
08720865786063Bella-muU-Needle B.V.FMI2025-10-29
08586015049729SelfinjectCHIRANA T.Injecta, a. s.FMF2025-10-03
08586015049729SelfinjectCHIRANA T.Injecta, a. s.FMI2025-10-03
08586015049743SelfinjectCHIRANA T.Injecta, a. s.FMI2025-10-03
08586015049743SelfinjectCHIRANA T.Injecta, a. s.FMF2025-10-03
08586015049767SelfinjectCHIRANA T.Injecta, a. s.FMI2025-10-03