Biotronix Healthcare Blunt Fill Needles with Filters

Basic Information

• Brand Name: Biotronix Healthcare Blunt Fill Needles with Filters
• Primary DI: 00850005165316
• Version / Model: GEBF5006
• Catalog Number: GEBF5006
• Company Name: BIOTRONIX HEALTHCARE INDUSTRIES, INC.
• Labeler DUNS: 065762392
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-10-12
• Public Version: 2
• Public Version Date: 2019-12-24
• Public Version Status: Update
• Public Device Record Key: 486c8260-31c5-4229-af47-af4b26be5d39

Device Description

Blunt Fill Needle with Filters 18G 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: Yes
• 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
GAA	Needle, Aspiration And Injection, Disposable	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
16266	Medication transfer needle, filtering	A slender, rigid, sharp or blunt tube intended to be attached to a syringe and typically used in the pharmacy to aspirate and transfer fluid medication from a vial/ampule to another container for medication preparation or other purposes. It includes an integral filter (e.g., a microporous stainless steel filter) intended to retain micro-particles from the drug as it flows through the needle to reduce the risk of particle contamination of the patient medication; it does not include a back-pressure venting feature. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20850005165310	GS1	Case	10	In Commercial Distribution
Package	10850005165313	GS1	Inner Box	100	In Commercial Distribution
Primary	00850005165316	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Blunt Fill Needle with Filters 18G x 1 1/2"