EasyTouch

Basic Information

• Brand Name: EasyTouch
• Primary DI: MHC1808002
• Version / Model: 808002
• Company Name: MHC MEDICAL PRODUCTS, LLC
• Labeler DUNS: 169895245
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-11-10
• Public Version: 1
• Public Version Date: 2025-11-18
• Public Version Status: New
• Public Device Record Key: b064438b-b091-4189-9148-cab908602fee

Device Description

EasyTouch Lancing Device

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• 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: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
QRL	Multiple Use Blood Lancet For Single Patient Use Only	General, Plastic Surgery	878.4850	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61578	Manual blood lancing device, single-use	A sterile, hand-held manual instrument intended to be used for controlled skin puncture/cut to obtain a capillary blood specimen, performed by a healthcare provider (e.g., on a neonate) or a patient (e.g., a diabetic), typically at the fingertip or ear lobe. It includes a preloaded lancet tip, and has a manually-powered mechanism (e.g., spring-loaded) which enables the tip to puncture to a predetermined depth and blood subsequently to be squeezed out of the puncture site. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	MHC1808002	HIBCC

Premarket Submissions

Submission Number	Supplement Number
K222472	000