STERISURE

GUDID B234KMHSS2100115V2

STATIC DRY HEAT STERILIZER

CPAC EQUIPMENT, INC.

Dry-heat sterilizer

• Primary Device ID: B234KMHSS2100115V2
• NIH Device Record Key: 1a10e641-41f3-4e2d-a3b0-af2afad17339
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: STERISURE
• Version Model Number: 2100
• 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	B234KMHSS2100115V2 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K771070

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: 2018-08-24

On-Brand Devices [STERISURE]

• B234KMHSS3100230V1: STATIC DRY HEAT STERILIZER
• B234KMHSS3100115V3: STATIC DRY HEAT STERILIZER
• B234KMHSS2100230V0: STATIC DRY HEAT STERILIZER
• B234KMHSS2100115V2: STATIC DRY HEAT STERILIZER
• B234FRGDHSB400597: STERISURE DRY HEAT STERILIZER BAGS, PAPER 2.5" X 1.5" X 10.5", 250/BOX