gudid Primary ID: 4010-U-F

Rescuer Manual Resuscitator (UDI 4010-U-F)

Data verified against official FDA/EUDAMED records on August 9, 2026

Scannable UDI-DI Representation

Device Regulatory Overview

The Rescuer Manual Resuscitator (Model/Catalog Number: 4010-U-F) is a medical device manufactured by B.L.S. Systems Limited. This product is indexed under FDA Product Code / Category Classification BTM within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number: 4010-U-F
Product Code / EMDN: BTM
Device Name: Child Size Rescuer Manual Resuscitator with universal tubing and filter
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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Frequently Asked Questions

Who is the primary manufacturer of Rescuer Manual Resuscitator?

The registered manufacturer of record for Rescuer Manual Resuscitator is B.L.S. Systems Limited.

What is the Primary UDI-DI identifier for Rescuer Manual Resuscitator?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 4010-U-F.

What classification code is assigned to this device?

This device is registered under product classification code BTM.

Similar Classification Devices (BTM)

Other Devices by B.L.S. Systems Limited

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