Comfit Cuff Preformed Large 9"-17" H-CL22

GUDID 00073796832223

Comfit Blood Pressure Cuff Large 9" to 17"

Omron Healthcare, Inc.

Blood pressure cuff, reusable

• Primary Device ID: 00073796832223
• NIH Device Record Key: 024eaa77-86b7-41de-9eac-9d965a5b5af8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Comfit Cuff Preformed Large 9"-17"
• Version Model Number: H-CL22
• Catalog Number: H-CL22
• Company DUNS: 054318779
• Company Name: Omron Healthcare, 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: true
• Serial Number: false
• Manufacturing Date: false
• 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: true

Customer Support Contacts

• Phone: 1-800-634-4350
• Email: ohiquality@omron.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00073796832223 [Primary]
GS1	10073796832220 [Package]; Package: InnerCarton [10 Units]; In Commercial Distribution
GS1	20073796832227 [Package]; Contains: 10073796832220; Package: Case [2 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K042506

FDA Product Code

• DXN: System, Measurement, Blood-Pressure, Non-Invasive

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-07-22
• Device Publish Date: 2016-09-16

On-Brand Devices [Comfit Cuff Preformed Large 9"-17"]

• 00073796832223: Comfit Blood Pressure Cuff Large 9" to 17"
• 00073796223144: Comfit Blood Pressure Cuff (Large 9" to 17")