Duns Number:305682023
Device Description: Ambu Cuff Pressure Gauge, for inflating and testing cuffs Tube length 100 cm, luer type co Ambu Cuff Pressure Gauge, for inflating and testing cuffs Tube length 100 cm, luer type connection
Catalog Number
321900000
Brand Name
Ambu Cuff Pressure Gauge
Version/Model Number
321900000
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
August 29, 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
-
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
K912723,K912723
Product Code
BSK
Product Code Name
Cuff, tracheal tube, inflatable
Public Device Record Key
26ebd95e-7b78-4455-9e64-61b34f45866e
Public Version Date
August 30, 2022
Public Version Number
5
DI Record Publish Date
September 20, 2016
Package DI Number
05707480133086
Quantity per Package
42
Contains DI Package
05707480133079
Package Discontinue Date
August 29, 2022
Package Status
Not in Commercial Distribution
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 |