Duns Number:002348191
Device Description: PLEUR-EVAC MINI SAHARA LATEX FREE
Catalog Number
S-0500
Brand Name
PLEUR-EVAC
Version/Model Number
IPN028482
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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
KDQ
Product Code Name
BOTTLE, COLLECTION, VACUUM
Public Device Record Key
a4eb26ec-f410-49f6-af71-ab3d9a2637d9
Public Version Date
September 13, 2022
Public Version Number
3
DI Record Publish Date
July 09, 2019
Package DI Number
44026704631641
Quantity per Package
6
Contains DI Package
34026704631644
Package Discontinue Date
September 12, 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 | 3195 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 13747 |
| 3 | A medical device with high risk that requires premarket approval | 3 |
| U | Unclassified | 26 |