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Resp-O2 Tracheostomy Gauze Sponges, Sterile

FDA UDI

Class I (US FDA UDI)

by Dynarex Corp.

Identity

Trade Name
Resp-O2 Tracheostomy Gauze Sponges, Sterile FDA UDI
Generic Name
Tracheostomy tube dressing FDA UDI
Device Name
STERILE-EO , 100% Cotton, 4" x 4", 12-Ply FDA UDI
Model / Reference
35051 FDA UDI
Description
STERILE-EO , 100% Cotton, 4" x 4", 12-Ply FDA UDI

Identifiers

Primary DI / UDI-DI
00840117340244 FDA UDI
FDA Product Code
NAB FDA UDI
GMDN Term
Tracheostomy tube dressing FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.4014 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Tracheostomy tube dressing

Resp-O2 Tracheostomy Gauze Sponges, Sterile by Dynarex Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Tracheostomy tube dressing.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Dynarex Corp.

Sources (1)

  • FDA UDI 14ec36d4-8072-401d-97d7-e8b7f5899cc3 33 fields · synced May 30, 2026