NatureSpirit

GUDID 00897037001229

SIMPRO

Pulse oximeter, line-powered Pulse oximeter, line-powered Pulse oximeter, line-powered Pulse oximeter, line-powered Pulse oximeter, line-powered Pulse oximeter, line-powered Pulse oximeter, line-powered Pulse oximeter, line-powered Pulse oximeter, line-powered Pulse oximeter, line-powered Pulse oximeter, line-powered Pulse oximeter, line-powered Pulse oximeter, line-powered Pulse oximeter, line-powered Pulse oximeter, line-powered Pulse oximeter, line-powered Pulse oximeter, line-powered

• Primary Device ID: 00897037001229
• NIH Device Record Key: 464efde2-c046-418b-a928-dec4b83d263a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NatureSpirit
• Version Model Number: CMS-50D/CMS-50D1
• Company DUNS: 188434448
• Company Name: SIMPRO
• 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: 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00897037001229 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172141

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: 2
• Public Version Date: 2020-02-10
• Device Publish Date: 2019-03-29

On-Brand Devices [NatureSpirit]

• 00897037001014: Digital Arm Blood Pressure Monitor
• 00897037001229: CMS-50D/CMS-50D1
• 00897037001038: Bilingual Arm Blood Pressure Monitor