Duns Number:016898496
Device Description: Catheter and Glove Suction Kit with Solution Container, CSR Wrap and Two Vinyl Gloves
Catalog Number
0140080
Brand Name
Catheter and Glove Suction Kit
Version/Model Number
0140080
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)
-
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
BSY
Product Code Name
CATHETERS, SUCTION, TRACHEOBRONCHIAL
Public Device Record Key
a20c162c-4095-40a0-986c-a15595730307
Public Version Date
May 18, 2022
Public Version Number
2
DI Record Publish Date
September 21, 2020
Package DI Number
10801741050678
Quantity per Package
50
Contains DI Package
00801741050671
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 |