ProChek ID SM4340-1

GUDID H816SM43402

Indicator Strips for Steam and Chemical Vapor

CERTOL INTERNATIONAL, LLC

Chemical/physical sterilization process indicator

• Primary Device ID: H816SM43402
• NIH Device Record Key: d6022317-8a0b-4fa1-8d5d-d29ba97dd894
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ProChek ID
• Version Model Number: SM4340
• Catalog Number: SM4340-1
• Company DUNS: 095153714
• Company Name: CERTOL INTERNATIONAL, LLC
• Device Count: 250
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	H816SM43400 [Unit of Use]
HIBCC	H816SM43401 [Primary]
HIBCC	H816SM43402 [Package]; Contains: H816SM43401; Package: Case Box [6 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K951113

FDA Product Code

• LRT: Indicator, Sterilization

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-23

On-Brand Devices [ProChek ID]

• H816SM43402: Indicator Strips for Steam and Chemical Vapor
• H816PIT3401: Steam Sterilization Indicator Tape
• H816PIT1201: Steam Sterilization Indicator Tape
• H816PIT1002: Steam Sterilization Indicator Tape