True Comfort Insulin Syringes 31G 1CC 5/16"

Basic Information

• Brand Name: True Comfort Insulin Syringes 31G 1CC 5/16"
• Primary DI: 00860000526562
• Version / Model: INS0531-0516
• Catalog Number: 1881
• Company Name: HOME AIDE DIAGNOSTICS, INC.
• Labeler DUNS: 783518983
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-10-08
• Public Version: 1
• Public Version Date: 2024-10-16
• Public Version Status: New
• Public Device Record Key: e786cdb2-861c-4764-b20f-c79c666b55fc

Device Description

(1cc)(5/16")(31G) Single use disposable insulin syringes. Includes 100 sterile needles individually wrapped.

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: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
Package	10860000526569	GS1	Case	20	In Commercial Distribution
Primary	00860000526562	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K230061	000

Device Sizes

Type	Value	Unit	Text
Needle Gauge	31	Gauge
Device Size Text, specify			1cc
Length	0.3125	Inch

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Insulin Syringes are disposable needles and should be discarded after each use. Store at room temperature in a dry cool place.