Duns Number:305682023
Device Description: Ambu TubeChek B, Bulb model Minimum order sales is 20 pcs.
Catalog Number
000172002
Brand Name
TubeChek-B
Version/Model Number
000172002
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
February 10, 2022
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
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
BTR
Product Code Name
Tube, tracheal (w/wo connector)
Public Device Record Key
19789359-20c2-475f-9571-6a8487832e36
Public Version Date
February 10, 2022
Public Version Number
3
DI Record Publish Date
January 07, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 309 |