Hy-Vee Health Premium Wrist BPM UB-543-HV

GUDID 00075450227406

Digital Blood Pressure Monitor

HY-VEE, INC.

Automatic-inflation electronic sphygmomanometer, non-portable

• Primary Device ID: 00075450227406
• NIH Device Record Key: 647d5e17-53db-4846-8663-8c53abaa040e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Hy-Vee Health Premium Wrist BPM
• Version Model Number: UB-543-HV
• Catalog Number: UB-543-HV
• Company DUNS: 006925671
• Company Name: HY-VEE, 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: 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: 1-888-726-9966
• Email: htn@andonline.com
• Phone: 1-888-726-9966
• Email: htn@andonline.com
• Phone: 1-888-726-9966
• Email: htn@andonline.com
• Phone: 1-888-726-9966
• Email: htn@andonline.com
• Phone: 1-888-726-9966
• Email: htn@andonline.com
• Phone: 1-888-726-9966
• Email: htn@andonline.com
• Phone: 1-888-726-9966
• Email: htn@andonline.com
• Phone: 1-888-726-9966
• Email: htn@andonline.com
• Phone: 1-888-726-9966
• Email: htn@andonline.com
• Phone: 1-888-726-9966
• Email: htn@andonline.com
• Phone: 1-888-726-9966
• Email: htn@andonline.com
• Phone: 1-888-726-9966
• Email: htn@andonline.com
• Phone: 1-888-726-9966
• Email: htn@andonline.com
• Phone: 1-888-726-9966
• Email: htn@andonline.com
• Phone: 1-888-726-9966
• Email: htn@andonline.com
• Phone: 1-888-726-9966
• Email: htn@andonline.com
• Phone: 1-888-726-9966
• Email: htn@andonline.com
• Phone: 1-888-726-9966
• Email: htn@andonline.com
• Phone: 1-888-726-9966
• Email: htn@andonline.com
• Phone: 1-888-726-9966
• Email: htn@andonline.com
• Phone: 1-888-726-9966
• Email: htn@andonline.com
• Phone: 1-888-726-9966
• Email: htn@andonline.com
• Phone: 1-888-726-9966
• Email: htn@andonline.com
• Phone: 1-888-726-9966
• Email: htn@andonline.com
• Phone: 1-888-726-9966
• Email: htn@andonline.com
• Phone: 1-888-726-9966
• Email: htn@andonline.com
• Phone: 1-888-726-9966
• Email: htn@andonline.com
• Phone: 1-888-726-9966
• Email: htn@andonline.com
• Phone: 1-888-726-9966
• Email: htn@andonline.com
• Phone: 1-888-726-9966
• Email: htn@andonline.com
• Phone: 1-888-726-9966
• Email: htn@andonline.com
• Phone: 1-888-726-9966
• Email: htn@andonline.com
• Phone: 1-888-726-9966
• Email: htn@andonline.com
• Phone: 1-888-726-9966
• Email: htn@andonline.com
• Phone: 1-888-726-9966
• Email: htn@andonline.com
• Phone: 1-888-726-9966
• Email: htn@andonline.com
• Phone: 1-888-726-9966
• Email: htn@andonline.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00075450227406 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141179

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: 5
• Public Version Date: 2019-11-08
• Device Publish Date: 2017-09-19

Devices Manufactured by HY-VEE, INC.

• 10075450136088 - Hy-Vee Health Tampons: 2019-12-09
• 10075450136095 - Hy-Vee Health Tampons: 2019-12-09
• 00075450227406 - Hy-Vee Health Premium Wrist BPM: 2019-11-08Digital Blood Pressure Monitor
• 00075450227406 - Hy-Vee Health Premium Wrist BPM: 2019-11-08 Digital Blood Pressure Monitor
• 00075450227420 - Hy-Vee Health Wireless BPM: 2019-11-08 Digital Blood Pressure Monitor
• 00075450227437 - Hy-Vee Health Multi-User BPM: 2019-11-08 Digital Blood Pressure Monitor
• 00075450123777 - HyVee Health: 2019-07-23 Hy-Vee DPS Early Result
• 00075450259339 - HyVee Health: 2019-07-23 FPPL Hy-Vee DPS +/- (ER)
• 10075450290803 - HyVee Health: 2019-07-23 FPPL Hy-Vee SPS +/- (ER)