ProCure™

Basic Information

• Brand Name: ProCure™
• Primary DI: 10840330703687
• Version / Model: PCSS825
• Catalog Number: PCSS825
• Company Name: Twin Med, LLC
• Labeler DUNS: 107071289
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-10-04
• Public Version: 1
• Public Version Date: 2023-10-12
• Public Version Status: New
• Public Device Record Key: 04cdc8e8-29e2-4f34-9bff-cc9409035f86

Device Description

ProCure Safe Insulin Safety Syringe 1/2cc 31g x 5/16" 100ea/bx 8bx/cs

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: 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
MEG	Syringe, Antistick	General Hospital	880.5860	2

GMDN Terms

Code	Name	Definition	Implantable	Status
34973	Insulin syringe/needle, safety	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; it includes an attached needle with a safety mechanism, such as cylinder/flap shielding or retraction into the barrel or sleeve after use, providing protection against needle sticks and rendering the device unusable. The syringe is typically made of plastic and silicone materials and will have plunger anti-sticking properties (internally precoated with compatible substances) allowing smooth plunger movement. It can be used by healthcare personnel or patients.. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	30840330703681	GS1	Box	100	In Commercial Distribution
Primary	10840330703687	GS1
Package	50840330703685	GS1	Case	8	In Commercial Distribution

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K150758	000

Device Sizes

Type	Value	Unit	Text
Length	4.5	Inch
Needle Gauge	31	Gauge
Outer Diameter	.3125	Inch
Total Volume	.5	Milliliter

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Keep Dry, Keep away from Direct Sunlight
• Type: Handling Environment Temperature
• Temperature Range: – 104 Degrees Fahrenheit