STERIDENT

GUDID B234KMHSD301000115

STERIDENT 115V MODEL

CPAC EQUIPMENT, INC.

Dry-heat sterilizer

• Primary Device ID: B234KMHSD301000115
• NIH Device Record Key: 1c4daec0-4828-4958-be2a-ac8fb9b3fbb2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: STERIDENT
• Version Model Number: 300
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• 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	B234KMHSD301000115 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K094026

FDA Product Code

• KMH: Sterilizer, Dry Heat

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-10-01
• Device Publish Date: 2018-08-31

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