ProChek S

Basic Information

• Brand Name: ProChek S
• Primary DI: H816MTSI4401
• Version / Model: TSI440
• Catalog Number: TSI440-1
• Company Name: MicroCare, LLC
• Labeler DUNS: 118518186
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2022-10-26
• Public Version: 2
• Public Version Date: 2025-02-21
• Public Version Status: Update
• Public Device Record Key: 0b7d92c3-b5ac-45c1-a491-2c0cbd13f312

Device Description

Steam Sterilization Integrators

Device Characteristics

• Single Use: Yes
• 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: No
• 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
JOJ	Indicator, Physical/Chemical Sterilization Process	General Hospital	880.2800	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35362	Chemical/physical sterilization process indicator	A sterilization indicator designed to be placed within a sterilizing chamber, and to respond with a characteristic chemical and/or physical change (non-electrical) to one or more of the physical conditions within the chamber, to validate the sterilization process. It may be presented in one of a variety of forms (e.g., tape, test pack, tag). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	H816MTSI4402	HIBCC		6	In Commercial Distribution
Primary	H816MTSI4401	HIBCC
Unit of Use	H816MTSI4400	HIBCC
Previous	H816TSI4401	HIBCC

Premarket Submissions

Submission Number	Supplement Number
K060103	000