True Comfort Twist Top Lancets 30G

Basic Information

• Brand Name: True Comfort Twist Top Lancets 30G
• Primary DI: 00860000526500
• Version / Model: 6500
• Company Name: HOME AIDE DIAGNOSTICS, INC.
• Labeler DUNS: 783518983
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-10-08
• Public Version: 1
• Public Version Date: 2024-10-16
• Public Version Status: New
• Public Device Record Key: bf98792a-1b74-437b-9c62-ec704c3cfa95

Device Description

• 30 Gauge • Twist top lancets • Single use • Provides virtually painless testing • Comfort depth penetration • Smooth tri-bevel point • 100 sterile tip lancets per box

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
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
Package	10860000526507	GS1	Case	200	In Commercial Distribution
Primary	00860000526500	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K223314	000

Device Sizes

Type	Value	Unit	Text
Needle Gauge	30	Gauge