GUDIDData
gudid Primary ID: 35051

Resp-O2 Tracheostomy Gauze Sponges, 100% Cotton, 12-Ply, 4" x 4" (UDI 35051)

Manufactured by Dynarex Corporation

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for Resp-O2 Tracheostomy Gauze Sponges, 100% Cotton, 12-Ply, 4" x 4" - Primary ID 35051

Device Regulatory Overview

The Resp-O2 Tracheostomy Gauze Sponges, 100% Cotton, 12-Ply, 4" x 4" (Model/Catalog Number: 35051) is a medical device manufactured by Dynarex Corporation. This product is indexed under FDA Product Code / Category Classification NAB 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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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
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Technical Specifications

Model Number
35051
Product Code / EMDN
NAB
Device Name
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 Tracheostomy Gauze Sponges, 100% Cotton, 12-Ply, 4" x 4"?

The registered manufacturer of record for Resp-O2 Tracheostomy Gauze Sponges, 100% Cotton, 12-Ply, 4" x 4" is Dynarex Corporation.

What is the Primary UDI-DI identifier for Resp-O2 Tracheostomy Gauze Sponges, 100% Cotton, 12-Ply, 4" x 4"?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 35051.

What classification code is assigned to this device?

This device is registered under product classification code NAB.

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