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gudid Primary ID: 36001

Resp-O2 Manual Pulmonary Resuscitator (MPR) (UDI 36001)

Manufactured by Dynarex Corporation

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for Resp-O2 Manual Pulmonary Resuscitator (MPR) - Primary ID 36001

Device Regulatory Overview

The Resp-O2 Manual Pulmonary Resuscitator (MPR) (Model/Catalog Number: 36001) is a medical device manufactured by Dynarex Corporation. This product is indexed under FDA Product Code / Category Classification BTM within international Unique Device Identification (UDI) compliance databases.

ACTIVE SAFETY RECALL ALERT 3 Event(s) Found

Enforcement actions are currently active for this product line.

ID: Z-2057-2016 View Full Alert →

dynarex Specimen Containers, Screw-On, Leak-Resistant Lid, Tamper-Evident Seal, Sterile, Single Use Only Product Usage:containers for sam...

🔒 Compromised Lot & Serial Numbers Locked
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Unlock Lot Data ($49)
ID: Z-2117-2014 View Full Alert →

CPR Shield With One Way Valve and Barrier Filter, Reorder No. 4921 --- Dynarex label, 100 per case --- Manufactured for: Dynarex Corporation...

🔒 Compromised Lot & Serial Numbers Locked
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ID: Z-1955-2018 View Full Alert →

Dynarex CGA870 All Brass Oxygen Regulator, All Brass - 0-25 LPM, Barb & 2-DISS Outlet, UPC: 616784522715, Model Number 5227 A pressure r...

🔒 Compromised Lot & Serial Numbers Locked
Verify if facility inventory is affected by this recall.
Unlock Lot Data ($49)

Technical Specifications

Model Number
36001
Product Code / EMDN
BTM
Device Name
Mask, Reservoir Tubing, Oxygen Tubing, Adult
Database Sync Date
2026-08-09 09:00:28

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 Resp-O2 Manual Pulmonary Resuscitator (MPR)?

The registered manufacturer of record for Resp-O2 Manual Pulmonary Resuscitator (MPR) is Dynarex Corporation.

What is the Primary UDI-DI identifier for Resp-O2 Manual Pulmonary Resuscitator (MPR)?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 36001.

What classification code is assigned to this device?

This device is registered under product classification code BTM.

Similar Classification Devices (BTM)

Other Devices by Dynarex Corporation

Programmatic Export

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