Identity
- Trade Name
- AMC FDA UDI
- Generic Name
- Telemetric pulse oximeter FDA UDI
- Device Name
- Datascope comp., Adult Reusable SpO2 Finger Sensor FDA UDI
- Model / Reference
- PR-A520-1004 FDA UDI
- Description
- Datascope comp., Adult Reusable SpO2 Finger Sensor FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00849593041157 FDA UDI
- FDA Product Code
- DQA FDA UDI
- GMDN Term
- Telemetric pulse oximeter FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Category: Telemetric pulse oximeter
Amc by Advantage Medical Electronics, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Telemetric pulse oximeter.
- VIVE — VIVE HEALTH LLC · Class II
- Tenovi — TENOVI CO · Class II
- Areta Fingertip Pulse Oximeter — EASY HEALTHCARE CORPORATION · Class II
- Vermed — GRAPHIC CONTROLS ACQUISITION CORP · Class II
- Vermed — GRAPHIC CONTROLS ACQUISITION CORP · Class II
- Vermed — GRAPHIC CONTROLS ACQUISITION CORP · Class II
- Vermed — GRAPHIC CONTROLS ACQUISITION CORP · Class II
- Easy@Home Fingertip Pulse Oximeter — EASY HEALTHCARE CORPORATION · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Advantage Medical Electronics, LLC
Sources (1)
- FDA UDI 25c30a01-0e26-46be-b732-e73ddff1bf59 34 fields · synced May 30, 2026