GoodSense Comfort Assist Insulin Syringes

Basic Information

• Brand Name: GoodSense Comfort Assist Insulin Syringes
• Primary DI: 00370030128709
• Version / Model: 052912
• Company Name: L PERRIGO COMPANY
• Labeler DUNS: 006013346
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 4
• Public Version Date: 2019-07-11
• Public Version Status: Update
• Public Device Record Key: 7c730b54-6c22-40c2-b796-11cf8296f396
• Distribution End Date: 2018-08-07

Device Description

.5cc 12.7mm 29G Insulin Syringe, Sterile, Single-Use, 100ct

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: Yes
• 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: 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
FMI	Needle, Hypodermic, Single Lumen	General Hospital	880.5570	2

GMDN Terms

Code	Name	Definition	Implantable	Status
38501	Insulin syringe/needle, basic	A sterile device consisting of a calibrated barrel (cylinder) with plunger intended to be used to administer an injection of insulin to a patient subcutaneously; a non-retractable needle is included, either attached or detached (usually capped for user protection). The syringe is typically made of plastic and silicone materials and will have plunger anti-sticking properties allowing smooth plunger movement. It can be used by healthcare personnel or patient, and will allow for the aspiration of the pharmaceutical from its container for direct administration to the patient or via an intravenous (IV) port, heparin lock, or saline lock. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10370030128706	GS1	Shipper	30	Not in Commercial Distribution	2018-08-07
Primary	00370030128709	GS1
Unit of Use	10070030510708	GS1

Premarket Submissions

Submission Number	Supplement Number
K062702	000

Device Sizes

Type	Value	Unit	Text
Total Volume	.5	Milliliter
Needle Gauge	29	Gauge
Length	12.7	Millimeter