HealthSmart 04-645-001

GUDID 10767056645018

SELECT DIGITAL ARM BLOOD PRESSURE MONITOR ADULT

D-M-S HOLDINGS, INC.

Automatic-inflation electronic sphygmomanometer, portable, arm/wrist

• Primary Device ID: 10767056645018
• NIH Device Record Key: 870c1c91-bbac-4afc-bbd9-1381e1f57d60
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HealthSmart
• Version Model Number: 04-645-001
• Catalog Number: 04-645-001
• Company DUNS: 062028220
• Company Name: D-M-S HOLDINGS, 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: 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00767056645011 [Primary]
GS1	10767056645018 [Package]; Contains: 30767056645012; Package: Master Carton [4 Units]; In Commercial Distribution
GS1	30767056645012 [Package]; Contains: 00767056645011; Package: Inner Carton [3 Units]; In Commercial Distribution

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: 3
• Public Version Date: 2019-11-08
• Device Publish Date: 2016-09-23

On-Brand Devices [HealthSmart]

• 10767056820019: PREMIUM WRIST DIGITAL BP ADULT TALKING
• 30767056810014: STANDARD WRIST DIGITAL BP ADULT
• 10767056655017: PREMIUM DIGITAL ARM BP ADULT TALKING
• 10767056645018: SELECT DIGITAL ARM BLOOD PRESSURE MONITOR ADULT
• 10767056635019: STANDARD DIGITAL ARM BP ADULT
• 10767056240060: BP Replacement Cuff
• 10767056240046: BP Replacement Cuff
• 10767056240015: BP Replacement Cuff
• 10767056224008: BP AC Adapter
• 10767056189352: DIGISCAN INFRARED TALKING THERMOMETER
• 10767056185453: NON-CONTACT THERMOMETER
• 10767056182254: STANDARD EAR THERMOMETER LENS COVERS
• 10767056182209: STANDARD EAR THERMOMETER
• 10767056182100: COMPACT EAR THERMOMETER
• 10767056176062: TWO PARTY HOME BP UNIT BLACK LARGE ADULT
• 10767056174068: SELF TAKING HOME BP UNIT BLACK LARGE ADULT
• 10767056041766: TWO PARTY HOME BP UNIT BLACK ADULT
• 10767056041742: SELF TAKING HOME BP UNIT BLACK ADULT
• 00767056180253: Standard Pulse Oximeter, RED LED
• 00767056180277: Digital Deluxe Fingertip Pulse Oximeter – Two Color Display
• 00767056180260: Digital Standard Fingertip Pulse Oximeter - Green Display
• 00041298991496: 5” Toilet Seat Riser
• 10767056180878: TALKING ARM BP ADULT
• 30767056046154: DIGITAL BP WRIST MONITOR
• 10767056180922: Pulse Oximeter - Standard
• 10767056180601: H+S - Touchless Infrared Thermometer
• 30041298643907: Pill Crusher
• 10041298154379: Pill Cutter
• 10041298370090: Fold-Away Wall Mount Shower Seat
• 10767056181257: Universal Blood Pressure Cuff
• 30767056181060: Cordless Water Flosser Replacement Tips (4/pk)
• 10767056180977: Cordless Water Flosser
• 10767056181523: Battery Powered Nasal Aspirator
• 10767056181530: Battery Powered Nasal Aspirator