3Dose 1ml Syringe

Primary DI
08682747029296
Brand
3Dose 1ml Syringe
Company
BIMED TEKNIK ALETLER SANAYI VE TICARET ANONIM SIRKETI
Model
3DG125
Published
2025-09-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
K250733000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K2507330003DOSE 1ml SyringeBimed Teknik Aletler Sanayi & Ticaret A.S.2025-07-03FMF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08682747053406PackageGS110In Commercial Distribution
08682747053413PackageGS124In Commercial Distribution
08682747053451PackageGS110In Commercial Distribution
08682747053468PackageGS124In Commercial Distribution
08682747055998PackageGS1360In Commercial Distribution
08682747056001PackageGS1768In Commercial Distribution
08682747056018PackageGS1360In Commercial Distribution
08682747056025PackageGS1768In Commercial Distribution
08682747029296PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08682747053406086827470534068682747053406
08682747053413086827470534138682747053413
08682747053451086827470534518682747053451
08682747053468086827470534688682747053468
08682747055998086827470559988682747055998
08682747056001086827470560018682747056001
08682747056018086827470560188682747056018
08682747056025086827470560258682747056025
08682747029296086827470292968682747029296

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose syringe, single-useA sterile device consisting of a calibrated barrel (cylinder) with plunger intended to be used for injection/withdrawal of fluids/gas (e.g., medication) to/from a medical device or the body (i.e., capable of both); a needle is not included. It is intended for various medical applications and is not dedicated to medication administration. At the distal end of the barrel is a male connector (typically Luer-lock/slip type) for the attachment to a hypodermic needle or an administration set. It is typically made of plastic and silicone materials and may have anti-stick plunger allowing smooth plunger movement, either manually or by a syringe pump. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity00
Storage Environment Temperature00

Regulatory Flags#

DUNS number
644547838
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
086827470293023Dose 1ml Syringe3DO1002025-09-02

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