FDA UDI
In Commercial Distribution
🇺🇸 United States
Guardian Angel™ Rx
DI: 04719872650096
·
Model: GA1000Rx-A
·
AULISA MEDICAL USA, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Guardian Angel™ Rx
- Primary DI
- 04719872650096
- Version / Model
- GA1000Rx-A
- Company Name
- AULISA MEDICAL USA, INC.
- Labeler DUNS
- 116820893
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-06-03
- Public Version
- 1
- Public Version Date
- 2019-06-11
- Public Version Status
- New
- Public Device Record Key
- 0329a9f8-ec26-446f-92af-a0cbd55b8934
Device Description
Digital Vital Sign Monitoring System (with two Adult Oximeter Sensor Cables), RX ONLY
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| DQA | Oximeter | Cardiovascular | 870.2700 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36118 | Pulse oximetry telemetric monitoring system | An assembly of devices designed to continuously measure and wirelessly transmit haemoglobin oxygen saturation (SpO2) signals from a patient to a receiving location (e.g., central station, bedside monitor) for viewing. It typically consists of a portable transmitter with antenna and attached sensors (e.g., leads and electrodes) that are connected to the patient, as well as a receiver typically incorporated into a central station or bedside monitor that receives, consolidates, and displays the information. The system is typically used for ambulatory patients who require continuous monitoring (e.g., patients in step-down care areas). | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 14719872650093 | GS1 | 1 | In Commercial Distribution | ||
| Primary | 04719872650096 | GS1 |