Duns Number:008124539
Device Description: (1) Three-compartment tray(1) Pair of vinyl gloves(1) 3-Ply waterproof drape(4) Non-woven (1) Three-compartment tray(1) Pair of vinyl gloves(1) 3-Ply waterproof drape(4) Non-woven gauze, 4" × 4"(1) Tracheostomy dressing(2) Cotton-tipped applicators(1) Twill tape(2) Pipe cleaners(1) Tracheostomy brush(2) Hydrogen peroxide 1 oz. pack
Catalog Number
-
Brand Name
Resp-O2 Tracheostomy Care Kit, 3-Compartment Tray, Vinyl Gloves
Version/Model Number
35006
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
LRQ
Product Code Name
Tracheostomy And Nasal Suctioning Kit
Public Device Record Key
7dc0f00c-765c-4966-82e7-db2b05ce9d64
Public Version Date
October 11, 2022
Public Version Number
1
DI Record Publish Date
October 03, 2022
Package DI Number
00840117321458
Quantity per Package
20
Contains DI Package
00840117321380
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 |