Duns Number:131855157
Device Description: Size: Standard 13 mm; Type: Radiopaque
Catalog Number
42013R
Brand Name
Montgomery® Safe-T-Tube™
Version/Model Number
42013R
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
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
K930150,K930150
Product Code
BTR
Product Code Name
Tube, Tracheal (W/Wo Connector)
Public Device Record Key
5ba54549-0ee9-4625-9abd-98eb06dc542f
Public Version Date
August 30, 2022
Public Version Number
4
DI Record Publish Date
September 20, 2015
Package DI Number
EBES42013R1
Quantity per Package
1
Contains DI Package
EBES42013R0
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 |