Biotronix Healthcare

Basic Information

• Brand Name: Biotronix Healthcare
• Primary DI: 00858835007035
• Version / Model: GE36416
• Catalog Number: GE36416
• Company Name: BIOTRONIX HEALTHCARE INDUSTRIES, INC.
• Labeler DUNS: 065762392
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-10-06
• Public Version: 3
• Public Version Date: 2019-12-24
• Public Version Status: Update
• Public Device Record Key: e77ceeb4-523e-4d88-aee2-b4b04229a2e9

Device Description

Disposable Hypodermic Needle 21G x 1 1/2

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FMI	Needle, Hypodermic, Single Lumen	General Hospital	880.5570	2

GMDN Terms

Code	Name	Definition	Implantable	Status
59230	Hypodermic needle, single-use	A 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20858835007039	GS1	Case	100	In Commercial Distribution
Package	10858835007032	GS1	Inner Box	100	In Commercial Distribution
Primary	00858835007035	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K050999	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Disposable Hypodermic Needle 21G x 1 1/2