Duns Number:324869601
Device Description: Suction Catheter for Manual Suction Pump
Catalog Number
-
Brand Name
n.a.
Version/Model Number
30-57-305
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
February 09, 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
GCY
Product Code Name
Apparatus, Suction, Single Patient Use, Portable, Nonpowered
Public Device Record Key
711b929a-4098-4397-bd52-f9172043161d
Public Version Date
February 10, 2022
Public Version Number
2
DI Record Publish Date
September 02, 2020
Package DI Number
14250105614951
Quantity per Package
10
Contains DI Package
04250105614954
Package Discontinue Date
February 09, 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 | 334 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 14 |