gudid
Primary ID: 8855
Rescuer II Compact CPAP System (UDI 8855)
Manufactured by B.L.S. Systems Limited
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for Rescuer II Compact CPAP System - Primary ID 8855
Device Regulatory Overview
The Rescuer II Compact CPAP System (Model/Catalog Number: 8855) is a medical device manufactured by B.L.S. Systems Limited. This product is indexed under FDA Product Code / Category Classification BYE within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- 8855
- Product Code / EMDN
- BYE
- Device Name
- Rescuer II Compact CPAP System is a more compact version of the Rescuer Emergency CPAP System. This device is intended for patients exhibiting signs of respiratory distress. Model 8855 is delivered with the #4 cushion mask and head strap.
- Database Sync Date
- 2026-08-09 09:16:44
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 Rescuer II Compact CPAP System?
The registered manufacturer of record for Rescuer II Compact CPAP System is B.L.S. Systems Limited.
What is the Primary UDI-DI identifier for Rescuer II Compact CPAP System?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 8855.
What classification code is assigned to this device?
This device is registered under product classification code BYE.
Similar Classification Devices (BYE)
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