FDA.reportPublic FDA data

CHIRAVAC

Primary DI
08586015044823
Brand
CHIRAVAC
Company
CHIRANA T.Injecta, a. s.
Model
"21G x 1"""
Catalog number
CHBCN21100
Device description
"Blood collection needle 21G x 1"" (0,8 x 25mm), 100pcs box, for single use. "
Published
2026-04-27
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
FMINeedle, Hypodermic, Single Lumen
JKATubes, Vials, Systems, Serum Separators, Blood Collection

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMINeedle, Hypodermic, Single LumenGeneral Hospital2
JKATubes, Vials, Systems, Serum Separators, Blood CollectionClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K201009000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K201009000CHIRAVAC Blood Collection NeedlesChirana T. Injecta2021-07-21JKA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
48586015044821PackageGS110In Commercial Distribution
08586015044823PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
4858601504482148586015044821
08586015044823085860150448238586015044823

GMDN Terms#

Term, Definition table
TermDefinition
Non-fixed blood collection needleA sharp bevel-edged, hollow tubular metal instrument intended to be used as part of a blood collection set for drawing blood from a patient; it does not include wings for fixation/placement (i.e., not a venous butterfly/scalp vein needle). It is intended to be connected to blood collection tubing and/or a blood collection Luer connector for transfer into a blood specimen receptacle. It may include a pre-attached blood collection tube spike and/or a safety cover; however, it does not include blood collection tubing or a tube holder (i.e., not a set). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Needle Gauge21Gauge

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
No natural rubber latex
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
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
08586015049637SelfinjectU100 1ml 27G x 1/2”AP03-19-002025-10-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08586015044786CHIRAVACCHIRANA T.Injecta, a. s.JKA2026-04-27
08586015044786CHIRAVACCHIRANA T.Injecta, a. s.FMI2026-04-27
08586015044793CHIRAVACCHIRANA T.Injecta, a. s.FMI2026-04-27
08586015044793CHIRAVACCHIRANA T.Injecta, a. s.JKA2026-04-27
08586015044809CHIRAVACCHIRANA T.Injecta, a. s.FMI2026-04-27
08586015044809CHIRAVACCHIRANA T.Injecta, a. s.JKA2026-04-27
08586015044816CHIRAVACCHIRANA T.Injecta, a. s.FMI2026-04-27
08586015044816CHIRAVACCHIRANA T.Injecta, a. s.JKA2026-04-27
08586015044830CHIRAVACCHIRANA T.Injecta, a. s.FMI2026-04-27
08586015044830CHIRAVACCHIRANA T.Injecta, a. s.JKA2026-04-27
08586015044847CHIRAVACCHIRANA T.Injecta, a. s.FMI2026-04-27
08586015044847CHIRAVACCHIRANA T.Injecta, a. s.JKA2026-04-27
08586015044854CHIRAVACCHIRANA T.Injecta, a. s.FMI2026-04-27
08586015044854CHIRAVACCHIRANA T.Injecta, a. s.JKA2026-04-27
08586015044861CHIRAVACCHIRANA T.Injecta, a. s.FMI2026-04-27
08586015044861CHIRAVACCHIRANA T.Injecta, a. s.JKA2026-04-27
08586015044878CHIRAVACCHIRANA T.Injecta, a. s.FMI2026-04-27
08586015044878CHIRAVACCHIRANA T.Injecta, a. s.JKA2026-04-27
08800145524667JBP Nanocannula 23Gx40mmFeeltech Co.,Ltd.FMI2026-04-16
08800052609242Sure Fine Pen Needle 32G x 4mmSHINA MED CORPORATIONFMI2026-03-25
08800052609259Sure Fine Pen Needle 31G x 8mmSHINA MED CORPORATIONFMI2026-03-25
08800052609266Sure Fine Pen Needle 32G x 6mmSHINA MED CORPORATIONFMI2026-03-25
08800052609273"Sure Fine Pen Needle 30G x 5/16"""SHINA MED CORPORATIONFMI2026-03-25
08800052609280Sure Fine Pen Needle 31G 5mmSHINA MED CORPORATIONFMI2026-03-25
08800052609297"Sure Fine Pen Needle 29G x 1/2"""SHINA MED CORPORATIONFMI2026-03-25
08720865786063Bella-muU-Needle B.V.FMI2025-10-29
08586015049729SelfinjectCHIRANA T.Injecta, a. s.FMI2025-10-03
08586015049743SelfinjectCHIRANA T.Injecta, a. s.FMI2025-10-03
08586015049767SelfinjectCHIRANA T.Injecta, a. s.FMI2025-10-03
08586026571417SelfinjectCHIRANA T.Injecta, a. s.FMI2025-10-03