Resp-O2 Tracheostomy Gauze Sponges, 100% Cotton, 12-Ply, 4" x 4" (UDI 35051)
Manufactured by Dynarex Corporation
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.
Enforcement actions are currently active for this product line.
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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
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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 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.
Similar Classification Devices (NAB)
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