Duns Number:058614483
Device Description: Extension Tube
Catalog Number
-
Brand Name
Puritan Bennett
Version/Model Number
180-05
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)
-
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
BSK
Product Code Name
Cuff, tracheal tube, inflatable
Public Device Record Key
b14b44f0-ec9c-4972-9d69-ff9ed063ed6e
Public Version Date
December 03, 2021
Public Version Number
3
DI Record Publish Date
June 07, 2021
Package DI Number
20884521782508
Quantity per Package
10
Contains DI Package
10884521782501
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
PACK_OR_INNER_PACK
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 132 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8540 |
| 3 | A medical device with high risk that requires premarket approval | 202 |
| U | Unclassified | 40 |