ProChek ID PIT120-1

GUDID H816PIT1201

Steam Sterilization Indicator Tape

CERTOL INTERNATIONAL, LLC

Sterilization packaging tape Sterilization packaging tape Sterilization packaging tape Sterilization packaging tape Sterilization packaging tape Sterilization packaging tape Sterilization packaging tape Sterilization packaging tape Sterilization packaging tape Sterilization packaging tape Sterilization packaging tape Sterilization packaging tape Sterilization packaging tape Sterilization packaging tape Sterilization packaging tape Sterilization packaging tape Sterilization packaging tape Sterilization packaging tape Sterilization packaging tape Sterilization packaging tape Sterilization packaging tape Sterilization packaging tape Sterilization packaging tape Sterilization packaging tape Sterilization packaging tape Sterilization packaging tape Sterilization packaging tape Sterilization packaging tape

• Primary Device ID: H816PIT1201
• NIH Device Record Key: e379b4a7-f9a9-44aa-9a9a-1e3222418585
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ProChek ID
• Version Model Number: PIT120
• Catalog Number: PIT120-1
• Company DUNS: 095153714
• Company Name: CERTOL INTERNATIONAL, LLC
• Device Count: 1
• 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	H816PIT1201 [Primary]
HIBCC	H816PIT1202 [Package]; Package: Case Box [12 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