RH-Pro11-230V

GUDID B234KMHRHPRO111230V1

High Velocity Hot Air Sterilizer - 230V

CPAC EQUIPMENT, INC.

Dry-heat sterilizer Dry-heat sterilizer Dry-heat sterilizer Dry-heat sterilizer Dry-heat sterilizer Dry-heat sterilizer Dry-heat sterilizer Dry-heat sterilizer Dry-heat sterilizer Dry-heat sterilizer Dry-heat sterilizer Dry-heat sterilizer

• Primary Device ID: B234KMHRHPRO111230V1
• NIH Device Record Key: 61d1562b-1bf2-432b-aae3-689e1ec52a8b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RH-Pro11-230V
• Version Model Number: RH-PRo11-230V
• 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	B234KMHRHPRO111230V1 [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: 2020-10-09
• Device Publish Date: 2020-10-01

Devices Manufactured by CPAC EQUIPMENT, INC.

• B234KMHRHPRO111230V1 - RH-Pro11-230V: 2020-10-09High Velocity Hot Air Sterilizer - 230V
• B234KMHRHPRO111230V1 - RH-Pro11-230V: 2020-10-09 High Velocity Hot Air Sterilizer - 230V
• B234KMHRHPRO9115V3 - RH-Pro9: 2020-10-09 High Velocity Hot Air Sterilizer - 115V
• B234KMHRHPRO9115V4 - RH-Pro9-230V: 2020-10-09 High Velocity Hot Air Sterilizer - 230V
• B234FRGSTMS400633 - STERIDENT: 2020-04-13 Spore Test Monitoring Service Dry Heat or Steam, Mail-in 12/box
• B234FRGSTMS400634 - STERIDENT: 2020-04-13 SPORE TEST KIT MONITORING SERVICE DRY HEAT OR STEAM, MAIL IN 52/BOX
• B234FRGDHSB400597 - STERISURE: 2019-11-08 STERISURE DRY HEAT STERILIZER BAGS, PAPER 2.5" X 1.5" X 10.5", 250/BOX
• B234FRGSSNP400636 - STERIDENT: 2019-11-08 Self-Seal Nylon Pouches 2" x 10" 100/Box
• B234FRGSSNP400637 - STERIDENT: 2019-11-08 Self-Seal Nylon Pouches 4" x 10" 100/Box