COX RAPIDHEAT COX-115V-16

GUDID B234KMHCX6000115V161

HIGH VELOCITY HOT AIR STERILIZER - 115V

CPAC EQUIPMENT, INC.

Dry-heat sterilizer

• Primary Device ID: B234KMHCX6000115V161
• NIH Device Record Key: d1b47aea-1b3f-4325-a26c-96d5788f6768
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: COX RAPIDHEAT
• Version Model Number: 6000-16
• Catalog Number: COX-115V-16
• 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	B234KMHCX6000115V161 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K881371

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: 2018-09-24
• Device Publish Date: 2018-08-23

On-Brand Devices [COX RAPIDHEAT]

• B234KMHCX6220230V163: HIGH VELOCITY HOT AIR STERILIZER - 230V
• B234KMHCX6220230V152: HIGH VELOCITY HOT AIR STERILIZER - 230V
• B234KMHCX6000115V161: HIGH VELOCITY HOT AIR STERILIZER - 115V
• B234KMHCX6000115V150: High-Velocity Hot Air Sterilizer-115V