FDA.reportPublic FDA data

BioCare Safety Needles

Primary DI
00858835007097
Brand
BioCare Safety Needles
Company
BIOTRONIX HEALTHCARE INDUSTRIES, INC.
Model
BIO-1044S
Catalog number
BIO-1044S
Device description
"Disposable BioGuard Safety Needles 30G x 1/2"""
Published
2019-10-07
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
MEGSyringe, Antistick

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMFSyringe, PistonGeneral Hospital2
FMINeedle, Hypodermic, Single LumenGeneral Hospital2
MEGSyringe, AntistickGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K112057000
K190183000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K112057000KDL SYRINGES AND NEEDLEShanghai Kindly Enterprise Dev. Group Co.,2011-12-14FMF
K190183000Hypodermic Safety Needle, Hypodermic Safety Needle with SyringeAnhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.2019-10-04MEG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10858835007094PackageGS1100In Commercial Distribution
20858835007091PackageGS18In Commercial Distribution
00858835007097PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085883500709410858835007094
2085883500709120858835007091
00858835007097008588350070978588350070970858835007097

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@biotronixhealthcare.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
00858835007257Biotronix Healthcare SyringesGE12032GE120322019-10-12
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09347144015004Metier MedicalMETIER MEDICAL LTDFMF2026-10-12
09347144016186Metier MedicalMETIER MEDICAL LTDFMF2026-10-12
09347144016216Metier MedicalMETIER MEDICAL LTDFMF2026-10-12
16972857299337Pen Needles ClassicSandstone Medical (Suzhou) Inc.FMI2026-10-11
16972857299290Easydrip Readygard DuoSandstone Medical (Suzhou) Inc.FMI2026-10-09
16972857299306Easydrip ReadygardSandstone Medical (Suzhou) Inc.FMI2026-10-09
16972857299313Easydrip ReadygardSandstone Medical (Suzhou) Inc.FMI2026-10-09
20612479288496McKessonMCKESSON MEDICAL-SURGICAL INC.MEG2026-10-08
20612479288496McKessonMCKESSON MEDICAL-SURGICAL INC.FMF2026-10-08
20612479288526McKessonMCKESSON MEDICAL-SURGICAL INC.MEG2026-10-08
20612479288526McKessonMCKESSON MEDICAL-SURGICAL INC.FMF2026-10-08
20612479288557McKessonMCKESSON MEDICAL-SURGICAL INC.MEG2026-10-08
20612479288588McKessonMCKESSON MEDICAL-SURGICAL INC.MEG2026-10-08
00050428167243TRUEplusTRIVIDIA HEALTH, INC.FMI2026-10-07
00050428167267TRUEplusTRIVIDIA HEALTH, INC.FMI2026-10-07
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