Duns Number:131855157
Device Description: Size: 6; Type: Radiopaque
Catalog Number
MTT-006
Brand Name
Moore Tracheostomy Tube
Version/Model Number
MTT-006
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Safe
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
-
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
K962240,K962240
Product Code
BTO
Product Code Name
Tube, Tracheostomy (W/Wo Connector)
Public Device Record Key
405e2124-914e-4cdc-aa93-d88c980d5ef7
Public Version Date
September 08, 2022
Public Version Number
1
DI Record Publish Date
August 31, 2022
Package DI Number
34063107102395
Quantity per Package
1
Contains DI Package
14063107102391
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 121 |
2 | A medical device with a moderate to high risk that requires special controls. | 211 |
U | Unclassified | 1 |