Guardian Angel™ Rx

GUDID 04719872650010

Digital Vital Sign Monitoring System (with Adult / Pediatric Oximeter Sensor Cable)

AULISA MEDICAL USA, INC.

Pulse oximetry telemetric monitoring system

• Primary Device ID: 04719872650010
• NIH Device Record Key: 721509a6-5854-46e7-9fa4-8aac03b962e5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Guardian Angel™ Rx
• Version Model Number: GA1000
• 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: true
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04719872650010 [Primary]
GS1	14719872650017 [Package]; Package: [1 Units]; In Commercial Distribution

FDA Product Code

• DQA: Oximeter

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: 2019-04-10
• Device Publish Date: 2018-12-14

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