Forsure

Basic Information

• Brand Name: Forsure
• Primary DI: 00897633001012
• Version / Model: 90018150
• Catalog Number: 90018150
• Company Name: FORSURE MEDICAL PRODUCTS LLC
• Labeler DUNS: 033809722
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-10-05
• Public Version: 6
• Public Version Date: 2020-11-09
• Public Version Status: Update
• Public Device Record Key: 73026963-190f-4720-b3cf-1a55bd635967

Device Description

A sterile, sharp bevel-edged, hollow tubular metal device intended to be used in conjunction with syringes, secondary medication sets, or phlebotomy equipment (e.g., blood collection adapters or holders) to prepare and administer fluids/medications/drugs to a patient and/or to withdraw(aspirate) fluids from a patient. This is a single-use device. NLXZ Hypodermic needle, single-use, sterile

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: 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: Yes

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: Yes
• Sterilization Methods: Ethylene Oxide

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	00897633001012	GS1
Package	20897633001016	GS1	case	1000	In Commercial Distribution

Device Sizes

Type	Value	Unit	Text
Length	1.5	Inch
Needle Gauge	18	Gauge

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: KEEP AWAY FROM HIGH TEMPERATURE AND HIGH HUMIDITY. KEEP CUSTODY AT NORMAL TEMPERATURE.
• Type: Special Storage Condition, Specify
• Special Conditions: DO NOT STORE IN DIRECT SUNLIGHT