← Back to catalogue

Guardian Angel™ Rx

FDA UDI

Class II (US FDA UDI)

by Aulisa Medical Usa, Inc.

Identity

Trade Name
Guardian Angel™ Rx FDA UDI
Generic Name
Pulse oximetry telemetric monitoring system FDA UDI
Device Name
Digital Vital Sign Monitoring System (with Infant Oximeter Module), RX ONLY FDA UDI
Model / Reference
GA2001Rx FDA UDI
Description
Digital Vital Sign Monitoring System (with Infant Oximeter Module), RX ONLY FDA UDI

Identifiers

Primary DI / UDI-DI
04719872650287 FDA UDI
510(k) Number
K191207 FDA UDI
FDA Product Code
DRG FDA UDI
DQA FDA UDI
GMDN Term
Pulse oximetry telemetric monitoring system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.2910 FDA UDI
870.2700 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Pulse oximetry telemetric monitoring system

Guardian Angel™ Rx by Aulisa Medical Usa, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Pulse oximetry telemetric monitoring system.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Aulisa Medical Usa, Inc.

Sources (1)

  • FDA UDI 4b335694-dfc0-45b7-a719-30f1e6cb31c4 34 fields · synced May 31, 2026