ProChek S TSI440-1

GUDID H816TSI4401

Steam Sterilization Integrators

CERTOL INTERNATIONAL, LLC

Chemical/physical sterilization process indicator

• Primary Device ID: H816TSI4401
• NIH Device Record Key: 3b1218ae-67d4-4117-8ea3-20048ce13f42
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ProChek S
• Version Model Number: TSI440
• Catalog Number: TSI440-1
• Company DUNS: 095153714
• Company Name: CERTOL INTERNATIONAL, LLC
• Device Count: 100
• 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	H816TSI4400 [Unit of Use]
HIBCC	H816TSI4401 [Primary]
HIBCC	H816TSI4402 [Package]; Package: [6 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K060103

FDA Product Code

• JOJ: Indicator, Physical/Chemical Sterilization Process

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

Devices Manufactured by CERTOL INTERNATIONAL, LLC

• H816QEZ22 - QEZ: 2023-06-12
• H816PFL0082 - Shield: 2020-05-06 High-Efficiency Face Mask with Headband
• H816PFLEL82 - Shield: 2020-05-06 High-Efficiency Face Mask w/ Earloop
• H816PM10161 - ProView plus: 2019-11-08 Self-Sealing Sterilization Pouch/Packaging 10" X 16"
• H816PM13181 - ProView plus: 2019-11-08 Self-Sealing Sterilization Pouch/Packaging 13" X 18"
• H816PM13191 - ProView plus: 2019-11-08 Self-Sealing Sterilization Pouch/Packaging 13" X 18"
• H816PM24402 - ProView plus: 2019-11-08 Self Sealing Sterilization Pouch/Packaging 2 1/4" x 4"
• H816PM27902 - ProView plus: 2019-11-08 Self Sealing Sterilization Pouch/Packaging 2 3/4" X 9"