GUDIDData
eudamed_udi Primary ID: 00606959008007

S PerforMax MPU INTL w/EE Leak 2 & SE, Plus 4 HG (UDI 00606959008007)

Manufactured by Respironics Inc.

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for S PerforMax MPU INTL w/EE Leak 2 & SE, Plus 4 HG - Primary ID 00606959008007

Device Regulatory Overview

The S PerforMax MPU INTL w/EE Leak 2 & SE, Plus 4 HG (Model/Catalog Number: 1052553) is a medical device manufactured by Respironics Inc.. This product is indexed under FDA Product Code / Category Classification R0301010202 within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number
1052553
Product Code / EMDN
R0301010202
Device Name
PerforMax EE Total Face Mask
Database Sync Date
2026-08-09 16:29:10

Full Regulatory Attributes

🔒 Token Gated
{
    "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 S PerforMax MPU INTL w/EE Leak 2 & SE, Plus 4 HG?

The registered manufacturer of record for S PerforMax MPU INTL w/EE Leak 2 & SE, Plus 4 HG is Respironics Inc..

What is the Primary UDI-DI identifier for S PerforMax MPU INTL w/EE Leak 2 & SE, Plus 4 HG?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 00606959008007.

What classification code is assigned to this device?

This device is registered under product classification code R0301010202.

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