Duns Number:787855907
Device Description: Laparoscopic Smoke Filtration Device
Catalog Number
BLAP100
Brand Name
PlumePort
Version/Model Number
SE
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
April 21, 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
NKC
Product Code Name
Tubing/Tubing With Filter, Insufflation, Laparoscopic
Public Device Record Key
553f0aa1-41ee-40fb-9e72-9bebb209bc05
Public Version Date
April 22, 2022
Public Version Number
3
DI Record Publish Date
January 13, 2017
Package DI Number
10851136002430
Quantity per Package
12
Contains DI Package
00851136002433
Package Discontinue Date
April 21, 2022
Package Status
Not in Commercial Distribution
Package Type
case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 6 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 104 |