FDA.reportPublic FDA data

Biotronix Healthcare Syringes

Primary DI
00858835007257
Brand
Biotronix Healthcare Syringes
Company
BIOTRONIX HEALTHCARE INDUSTRIES, INC.
Model
GE12032
Catalog number
GE12032
Device description
"Disposable 3CC, LL Syringe W/Needle, 22G x 1 1/2"", Each"
Published
2019-10-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

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
K060211000
K222124000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K060211000WUZHOU SYRINGE, WITH/WITHOUT NEEDLEWenzhou Wuzhou Group Co. , Ltd.2006-02-10FMF
K222124000Sterile Hypodermic Syringe with/without Needle, Hypodermic NeedleAnhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.2022-11-04FMI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10858835007254PackageGS1100In Commercial Distribution
20858835007251PackageGS110In Commercial Distribution
00858835007257PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085883500725410858835007254
2085883500725120858835007251
00858835007257008588350072578588350072570858835007257

GMDN Terms#

Term, Definition table
TermDefinition
Hypodermic needle, single-useA non-dedicated, sharp bevel-edged, hollow tubular device intended to be inserted beneath the skin of a patient while connected to a noninvasive device (e.g., syringe, secondary medication set) to administer and/or withdraw (aspirate) fluids/drugs; it may also be used for fluid/drug preparation. Some types are designed with a shielding mechanism (e.g., safety cap) for protection from sharp injuries. It is not specifically designed for blood collection or artery puncture, and does not have wings for fixation/placement (i.e., not a blood collection, intra-arterial, or venous butterfly needle). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Contacts#

Phone, Email table
PhoneEmail
786-473-9436mborges@biotornixhealthcare.com

Regulatory Flags#

DUNS number
065762392
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
00850005165576Biotroix Healthcare SyringesGE12010SGE12010S2024-03-11
00850005165798Biotronix Healthcare SyringesGE12035GE120352019-10-18
00858835007202Biotronix HealthCare SyringesGE12012GE120122019-10-10
00858835007219Biotronix HealthCare SyringesGE12010GE120102019-10-10
00858835007226Biotronix Healthcare SyringesGE12033GE120332019-10-10
00858835007233Biotronix Healthcare SyringesGE12034GE120342019-10-12
00858835007240Biotronix Healthcare SyringesGE12030GE120302019-10-12
00858835007264Biotronix Healthcare SyringesGE12029GE120292019-10-12
00858835007271Biotronix Healthcare SyringesGE12047GE120472019-10-12
00858835007288Biotronix Healthcare SyringesGE12055GE120552019-10-12
00858835007295Biotronix Healthcare SyringesGE12053GE120532019-10-12
00858835007318Biotronix Healthcare SyringesGE12023GE120232019-10-12
00858835007332Biotronix Healthcare SyringesGE12025GE120252019-10-12
00858835007349Biotronix Healthcare SyringesE12026GE120262019-10-12
00858835007356Biotronix Healthcare SyringesGE12027GE120272019-10-12
00858835007783Biotronix Healthcare SyringesGE12026GE120262019-10-12
00864085000405Biotronix Healthcare SyringesGE12085GE120852019-10-13
00864085000412Biotronix Healthcare SyringesGE12041GE120412019-10-13
00858835007004Biotronix HealthcareGE36419GE364192019-10-06
00858835007011Biotronix HealthcareGE36420GE364202019-10-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05391530754033Polycarbonate SyringeDMC MEDICAL LIMITEDFMF2026-09-27
05391530754057Polycarbonate SyringeDMC MEDICAL LIMITEDFMF2026-09-27
05391530754118Polycarbonate SyringeDMC MEDICAL LIMITEDFMF2026-09-27
05391530754149polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-09-27
05391530754170polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-09-27
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
10192253005059MonojectCardinal Health 200, LLCFMI2026-09-24
10809160538913HalyardMEDICAL ACTION INDUSTRIES INC.FMI2026-09-24
16972857299252REDOX SMART PAN Pen NeedleSandstone Medical (Suzhou) Inc.FMI2026-09-24
MHC18290272EasyTouchMHC MEDICAL PRODUCTS, LLCFMI2026-09-22
MHC18310472EasyTouchMHC MEDICAL PRODUCTS, LLCFMI2026-09-22
MHC18313672EasyTouchMHC MEDICAL PRODUCTS, LLCFMI2026-09-22
MHC18320872EasyTouchMHC MEDICAL PRODUCTS, LLCFMI2026-09-22
MHC18323672EasyTouchMHC MEDICAL PRODUCTS, LLCFMI2026-09-22
10192253070804MonojectCardinal Health 200, LLCFMF2026-09-21
M992MTINS01291271MedThermalCarelife (usa) Inc.FMF2026-09-18
M992MTINS0331081MedThermalCarelife (usa) Inc.FMF2026-09-18
00850091070013CoreCareCORECARE PRODUCTS INC.FMI2026-09-04
00850091070235CoreCareCORECARE PRODUCTS INC.FMI2026-09-04
00850091070242CoreCareCORECARE PRODUCTS INC.FMI2026-09-04
00850091070242CoreCareCORECARE PRODUCTS INC.FMF2026-09-04