FDA.reportPublic FDA data

Biotronix Healthcare Insulin Pen Needles

Primary DI
20858835007985
Brand
Biotronix Healthcare Insulin Pen Needles
Company
BIOTRONIX HEALTHCARE INDUSTRIES, INC.
Model
GE44004
Device description
Insulin Pen Needle 31G x 3/16"(5mm), Each
Published
2019-09-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
true
Sterile
true
Single use
true

Contact Domains#

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
K133058000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K133058000INSULIN PEN NEEDLEWenzhou Wuzhou Import & Export Co., Ltd.2014-02-25FMI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10858835007988PackageGS1100In Commercial Distribution
20858835007985PackageGS18In Commercial Distribution
00858835007981PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085883500798810858835007988
2085883500798520858835007985
00858835007981008588350079818588350079810858835007981

GMDN Terms#

Term, Definition table
TermDefinition
Autoinjector needleA device designed for the parenteral administration of a drug contained in a cartridge that forms part of, is attached to, or inserted into an autoinjector (drug pen injector). It is used by persons requiring regular, self-administrated dosages of insulin, hormones, or other pharmaceuticals. This device will typically be constructed as a double-ended, stainless steel needle of various sizes that is fixed to a threaded hub of plastic to which the drug pen injector is connected. This device is packaged in a sealed sterility barrier, and might include needle shielding safety features to reduce the risk of needle stick injury. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
786-473-9436MBORGES@BIOTRONIXHEALTHCARE.COM

Regulatory Flags#

DUNS number
065762392
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
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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

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