True Comfort Pro Pen Needles 5MM 31G

Basic Information

• Brand Name: True Comfort Pro Pen Needles 5MM 31G
• Primary DI: 00850027494074
• Version / Model: I12015 or INSP31-5
• Catalog Number: 1638
• Company Name: HOME AIDE DIAGNOSTICS, INC.
• Labeler DUNS: 783518983
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-03-24
• Public Version: 1
• Public Version Date: 2021-04-01
• Public Version Status: New
• Public Device Record Key: 1d00327d-d1cd-42f6-8154-0e5402ca518f

Device Description

100ct box. 31G x 5mm Sterile Single use disposable pen needle for use with most insulin delivery systems. 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
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	10850027494071	GS1	Outer Carton	50	In Commercial Distribution
Primary	00850027494074	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Length	5	Millimeter
Needle Gauge	31	Gauge

Storage Conditions

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