Duns Number:121225812
Device Description: Tube, Endo, Oral Preformed, Murphy, cuffed 3.0
Catalog Number
-
Brand Name
SourceMark
Version/Model Number
M0530C
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)
Yes
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
K042683,K042683,K042683
Product Code
BTR
Product Code Name
Tube, Tracheal (W/Wo Connector)
Public Device Record Key
5cafc918-3b53-4105-842b-6d8dfa64bdd1
Public Version Date
July 09, 2020
Public Version Number
7
DI Record Publish Date
August 26, 2016
Package DI Number
10897392003842
Quantity per Package
10
Contains DI Package
00897392001421
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 24 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 71 |