Regard

GUDID 30817357021166

Regard - ADULT-2T-Screw

HYGIA HEALTH SERVICES, INC.

Blood pressure cuff, reprocessed Blood pressure cuff, reprocessed Blood pressure cuff, reprocessed Blood pressure cuff, reprocessed Blood pressure cuff, reprocessed Blood pressure cuff, reprocessed Blood pressure cuff, reprocessed Blood pressure cuff, reprocessed Blood pressure cuff, reprocessed Blood pressure cuff, reprocessed Blood pressure cuff, reprocessed Blood pressure cuff, reprocessed Blood pressure cuff, reprocessed Blood pressure cuff, reprocessed

• Primary Device ID: 30817357021166
• NIH Device Record Key: f1f15134-9a8d-4434-b1c5-4bcd627aa644
• Commercial Distribution Discontinuation: 2019-07-31
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Regard
• Version Model Number: R39053
• 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	10817357021162 [Primary]
GS1	30817357021166 [Package]; Contains: 10817357021162; 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