STERIDENT

GUDID B234FRGSTMS400634

SPORE TEST KIT MONITORING SERVICE DRY HEAT OR STEAM, MAIL IN 52/BOX

CPAC EQUIPMENT, INC.

Biological sterilization indicator

• Primary Device ID: B234FRGSTMS400634
• NIH Device Record Key: 2465feef-87a9-4959-87fe-62baf85ee5a3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: STERIDENT
• Version Model Number: 400634
• Company DUNS: 601985976
• Company Name: CPAC EQUIPMENT, INC.
• 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: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B234FRGSTMS400634 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K023716

FDA Product Code

• FRC: Indicator, Biological 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: 2
• Public Version Date: 2020-04-13
• Device Publish Date: 2018-09-20

On-Brand Devices [STERIDENT]

• B234KMHSD301000230: STERIDENT 230V MODEL
• B234KMHSD301000115: STERIDENT 115V MODEL
• B234KMHSD201000230: STERIDENT 230V MODEL
• B234KMHSD201000115: STERIDENT MODEL 115V MODEL
• B234FRGSTMS400634: SPORE TEST KIT MONITORING SERVICE DRY HEAT OR STEAM, MAIL IN 52/BOX
• B234FRGSTMS400633: Spore Test Monitoring Service Dry Heat or Steam, Mail-in 12/box
• B234FRGSSNP400651: SELF-SEAL NYLON POUCHES 3" X 10" 100/BOX
• B234FRGSSNP400639: SELF-SEAL NYLON POUCHES 9.5" x 13" 100/BOX
• B234FRGSSNP400638: SELF-SEAL NYLON POUCHES 7" x 10.5" 100/BOX
• B234FRGSSNP400637: Self-Seal Nylon Pouches 4" x 10" 100/Box
• B234FRGSSNP400636: Self-Seal Nylon Pouches 2" x 10" 100/Box
• B234FRGDHIS400635: DRY HEAT INDICATOR STRIPS 4", 100/BOX