Advocate Pen Needle 31G 8MM

Basic Information

• Brand Name: Advocate Pen Needle 31G 8MM
• Primary DI: 00894046001738
• Version / Model: 615
• Catalog Number: 615
• Company Name: DIABETIC SUPPLY OF SUNCOAST, INC.
• Labeler DUNS: 043081723
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2016-08-20
• Public Version: 6
• Public Version Date: 2022-11-01
• Public Version Status: Update
• Public Device Record Key: 2b9d44fd-14b3-4a50-a639-6b86fefa32cd

Device Description

Advocate Pen Needle sterile 31G 8MM 5/16" 100 Count

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• 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
Primary	00894046001738	GS1
Package	10894046001735	GS1	Case	12	In Commercial Distribution
Unit of Use	40894046001736	GS1

Customer Contacts

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