Duns Number:006261481
Device Description: SUCTION GV100 GENTLE VENT PUMP 5PK 10L
Catalog Number
-
Brand Name
Gentle Vent™
Version/Model Number
GV100
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 19, 2017
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"
-
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K012538,K012538
Product Code
DWF
Product Code Name
CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
Public Device Record Key
5e22c4c9-34cb-4dc7-aca8-6352b4a8c650
Public Version Date
March 04, 2019
Public Version Number
4
DI Record Publish Date
June 13, 2016
Package DI Number
20721902350089
Quantity per Package
5
Contains DI Package
00721902350085
Package Discontinue Date
October 19, 2017
Package Status
Not in Commercial Distribution
Package Type
PK
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 102 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 20495 |
| 3 | A medical device with high risk that requires premarket approval | 3601 |