Duns Number:016898496
Device Description: Davol Suction Catheter X-Ray Opaque Rubber Bronchial Aspirating
Catalog Number
0107150
Brand Name
Davol Bronchial Aspirating Catheter
Version/Model Number
0107150
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
May 17, 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)
Yes
Device labeled as "Not made with natural rubber latex"
-
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
BSY
Product Code Name
CATHETERS, SUCTION, TRACHEOBRONCHIAL
Public Device Record Key
48269394-ea35-429e-bb27-dddcc000ce79
Public Version Date
May 18, 2022
Public Version Number
2
DI Record Publish Date
September 21, 2020
Package DI Number
10801741050500
Quantity per Package
100
Contains DI Package
00801741050503
Package Discontinue Date
December 31, 2019
Package Status
Not in Commercial Distribution
Package Type
CA
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 472 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1994 |
| U | Unclassified | 10 |