Firefly

Basic Information

• Brand Name: Firefly
• Primary DI: 00867396000317
• Version / Model: Catalog Number: 200-10
• Catalog Number: Catalog Number: 200-10
• Company Name: PHARMA TECH SOLUTIONS, INC.
• Labeler DUNS: 829145387
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2017-02-14
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 78794fac-f47b-4bef-930f-b4485835e275

Device Description

Single-Use Disposable Safety Lancets

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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FMK	Lancet, Blood	General, Plastic Surgery	878.4850	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61579	Blood lancet, single-use	A sterile, hand-held, sharply-pointed, non-mechanical, scalpel-like instrument intended to be used by a healthcare provider to manually puncture the skin of a patient to obtain a small blood specimen or drain a cyst or boil. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00867396000317	GS1
Unit of Use	00867396000300	GS1
Package	20867396000311	GS1		10	In Commercial Distribution
Package	10867396000314	GS1		50	In Commercial Distribution

Customer Contacts

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