Duns Number:080935429
Device Description: Tracheostomy Care Kit,Soft Pack
Catalog Number
47892
Brand Name
Argyle
Version/Model Number
47892
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
BTO
Product Code Name
Tube, tracheostomy (w/wo connector)
Public Device Record Key
383a16a6-261e-4a5f-b906-bc40fb5756cf
Public Version Date
June 17, 2019
Public Version Number
7
DI Record Publish Date
August 28, 2015
Package DI Number
20884527000309
Quantity per Package
50
Contains DI Package
10884527000302
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 | 672 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1692 |
| U | Unclassified | 17 |