MediHeel

Basic Information

• Brand Name: MediHeel
• Primary DI: 10732671120042
• Version / Model: 2004
• Catalog Number: 2004
• Company Name: AMITY HOLDINGS, LLC
• Labeler DUNS: 016069284
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 50
• Record Status: Published
• Publish Date: 2020-06-01
• Public Version: 1
• Public Version Date: 2020-06-09
• Public Version Status: New
• Public Device Record Key: 6dbcf299-3de4-437e-bbc1-cbd51da78e5b
• Distribution End Date: 2025-06-01

Device Description

Button-Activated Safety Heelstick Lancet

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: 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
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	20732671220046	GS1	Corrugate Carton	10	In Commercial Distribution	2025-06-01
Primary	10732671120042	GS1
Unit of Use	00732671020048	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Depth	0.85	Millimeter