Guardian Angel™ Rx

GUDID 04719872650089

Pediatric Oximeter Sensor Cable

AULISA MEDICAL USA, INC.

Pulse oximeter probe, reusable

• Primary Device ID: 04719872650089
• NIH Device Record Key: 2398b9f9-5f6a-4bb4-932a-74d48c51c9dc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Guardian Angel™ Rx
• Version Model Number: GA-RS0004
• 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: false
• 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	04719872650089 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162580

FDA Product Code

• DQA: Oximeter

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: 2019-04-22
• Device Publish Date: 2019-04-13

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