Duns Number:002418234
Device Description: Tracheostomy Care Set
Catalog Number
800
Brand Name
Busse Hospital Disposables
Version/Model Number
800
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"
Yes
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
NXA
Product Code Name
Tracheotomy Care Kit
Public Device Record Key
1a4b697e-eb02-4494-8425-2e06b71d42d9
Public Version Date
October 21, 2020
Public Version Number
3
DI Record Publish Date
September 02, 2016
Package DI Number
10849233010007
Quantity per Package
20
Contains DI Package
00849233010000
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 31 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 298 |