Duns Number:008124539
Device Description: Resp-O2 Tracheostomy Gauze Sponges, Sterile, 100% Cotton, 4" x 4", 12-Ply, 2 per pouch
Catalog Number
-
Brand Name
Resp-O2 Tracheostomy Gauze Sponges
Version/Model Number
35051
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
NAB
Product Code Name
Gauze / Sponge,Nonresorbable For External Use
Public Device Record Key
14ec36d4-8072-401d-97d7-e8b7f5899cc3
Public Version Date
May 10, 2022
Public Version Number
1
DI Record Publish Date
May 02, 2022
Package DI Number
00840117309852
Quantity per Package
6
Contains DI Package
00840117309845
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 694 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 226 |
| 3 | A medical device with high risk that requires premarket approval | 2 |