gudid
Primary ID: Model 1000
Algo SaMD (UDI Model 1000)
Manufactured by All.health, Inc.
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for Algo SaMD - Primary ID Model 1000
Device Regulatory Overview
The Algo SaMD (Model/Catalog Number: Model 1000) is a medical device manufactured by All.health, Inc.. This product is indexed under FDA Product Code / Category Classification PGJ within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- Model 1000
- Product Code / EMDN
- PGJ
- Device Name
- The all.health Algo SaMD Model 1000 oximeter is a pulse oximeter configured to operate in Software as a Medical Device (SaMD). The software device is intended to run remotely as an optional cloud service component of a complete all.health ICM system, a non-medical-device clinical decision support system. The software device collects input from compatible remote hardware sensor bands or other sensors, then filters, analyzes, and validates the collected data to produce a clinical-grade pulse measurement of heart rate (HRp), respiration rate (RRp), and blood oxygenation (SpO2%) for output, including outlier rejection, averages, trends, and ranges over time for the purpose of remote patient monitoring. Medical Device Info. Class II (enforcement discretion) medical device Regulation: Oximeter, 870.2700 Rx. Federal law (USA) restricts this product to sale by or on the order of a licensed practitioner.
- Database Sync Date
- 2026-08-09 09:49:17
Full Regulatory Attributes
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{
"review_panel": "AN",
"gudid_di_status": "Published",
"sterilization_methods": ["EO", "Gamma"],
"rx_only": true
}
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Get API Token Access ($49/mo)Frequently Asked Questions
Who is the primary manufacturer of Algo SaMD?
The registered manufacturer of record for Algo SaMD is All.health, Inc..
What is the Primary UDI-DI identifier for Algo SaMD?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is Model 1000.
What classification code is assigned to this device?
This device is registered under product classification code PGJ.
Similar Classification Devices (PGJ)
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