Regard

GUDID 30817357020459

Regard-SM ADULT-1T-Bay

HYGIA HEALTH SERVICES, INC.

Blood pressure cuff, reprocessed

• Primary Device ID: 30817357020459
• NIH Device Record Key: de25f704-81b7-46b0-a611-63f1bf4f16e5
• Commercial Distribution Discontinuation: 2019-07-31
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Regard
• Version Model Number: R39085
• Company DUNS: 177939027
• Company Name: HYGIA HEALTH SERVICES, 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: true
• Lot Batch: true
• Serial Number: false
• 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
GS1	10817357020455 [Primary]
GS1	30817357020459 [Package]; Contains: 10817357020455; Package: Box [20 Units]; Discontinued: 2021-03-19; Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K032821

FDA Product Code

• NPP: Reprocessed Blood Pressure Cuff

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: 2021-03-19
• Device Publish Date: 2016-09-28

On-Brand Devices [Regard]

• 30817357021876: Regard - Adult-2T-MQ
• 30817357021357: Regard Large ADULT-1T-Bay
• 30817357021166: Regard - ADULT-2T-Screw
• 30817357020534: Regard-ADULT-2T-Screw
• 30817357020459: Regard-SM ADULT-1T-Bay
• 10817357020271: Regard-ADULT LONG-1T-Bay
• 30817357020084: Regard - ADULT-1T-Bay