Advocate Syringes for U-100 Insulin 31G .3CC 5/16" Needle

Basic Information

• Brand Name: Advocate Syringes for U-100 Insulin 31G .3CC 5/16" Needle
• Primary DI: 00894046001820
• Version / Model: 613
• Catalog Number: 613S
• Company Name: DIABETIC SUPPLY OF SUNCOAST, INC.
• Labeler DUNS: 043081723
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2016-08-20
• Public Version: 7
• Public Version Date: 2022-11-01
• Public Version Status: Update
• Public Device Record Key: 5ee9a18d-8c49-45a9-b312-ac666a1c68f7

Device Description

Advocate Syringes for U-100 Insulin 31G .3CC 5/16" Needle, Single Use, Sleeve of 10

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
FMF	Syringe, Piston	General Hospital	880.5860	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35904	Metered-delivery hypodermic syringe	A sterile device consisting of a graduated barrel (cylinder) with plunger intended to be used to deliver (inject) or withdraw an accurate metered dose of a fluid to/from the body. The application of the content of this device may be in conjunction with an injector device (transcutaneous delivery) or through the traditional use of a needle (subcutaneous delivery). It may allow for retraction of an attached needle (safety syringe); the needle is not included. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00894046001820	GS1
Package	00894046001721	GS1	614	10	In Commercial Distribution
Unit of Use	10894046001827	GS1
Package	10894046001728	GS1	631	50	In Commercial Distribution

Customer Contacts

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