Duns Number:153608369
Device Description: TRACH CARE TRAY with Saline Jar
Catalog Number
MSTC-020829
Brand Name
MedStream
Version/Model Number
MSTC-02086429
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
April 17, 2019
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
Yes
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
b262de81-63c2-4819-8bb5-478e48eb912c
Public Version Date
October 21, 2020
Public Version Number
3
DI Record Publish Date
March 25, 2019
Package DI Number
10842472106982
Quantity per Package
30
Contains DI Package
00842472106985
Package Discontinue Date
April 17, 2019
Package Status
Not 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 | 202 |
2 | A medical device with a moderate to high risk that requires special controls. | 86 |