Guardian Angel™ Rx

GUDID 14719872650284

Digital Vital Sign Monitoring System (with Infant Oximeter Module), RX ONLY

AULISA MEDICAL USA, INC.

Pulse oximetry telemetric monitoring system

• Primary Device ID: 14719872650284
• NIH Device Record Key: 4b335694-dfc0-45b7-a719-30f1e6cb31c4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Guardian Angel™ Rx
• Version Model Number: GA2001Rx
• Company DUNS: 116820893
• Company Name: AULISA MEDICAL USA, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04719872650287 [Primary]
GS1	14719872650284 [Package]; Contains: 04719872650287; Package: [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191207

FDA Product Code

• DRG: Transmitters And Receivers, Physiological Signal, Radiofrequency

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-12-05
• Device Publish Date: 2019-11-27

On-Brand Devices [Guardian Angel™ Rx]

• 04719872650010: Digital Vital Sign Monitoring System (with Adult / Pediatric Oximeter Sensor Cable)
• 04719872650089: Pediatric Oximeter Sensor Cable
• 04719872650072: Adult Oximeter Sensor Cable
• 14719872650062: Digital Vital Sign Monitoring System (with two Pediatric Oximeter Sensor Cables), RX ONLY
• 14719872650055: Digital Vital Sign Monitoring System (with two Adult Oximeter Sensor Cables), RX ONLY
• 14719872650109: Digital Vital Sign Monitoring System (with two Pediatric Oximeter Sensor Cables), RX ONLY
• 14719872650093: Digital Vital Sign Monitoring System (with two Adult Oximeter Sensor Cables), RX ONLY
• 14719872650284: Digital Vital Sign Monitoring System (with Infant Oximeter Module), RX ONLY
• 14719872650031: Digital Vital Sign Monitoring System (with Infant Oximeter Module), RX ONLY
• 14719872650208: Digital Vital Sign Monitoring System (with two Pediatric Oximeter Sensor Cables), RX ONLY
• 14719872650192: Digital Vital Sign Monitoring System (with two Adult Oximeter Sensor Cables), RX ONLY