Duns Number:002348191
Device Description: PLEUR-EVAC AUTOTRANSFUSION BAG LATEX FREE
Catalog Number
A-1500-08LF
Brand Name
PLEUR-EVAC
Version/Model Number
IPN028440
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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
CAC
Product Code Name
APPARATUS, AUTOTRANSFUSION
Public Device Record Key
4edb0add-2b90-45a4-a119-1c047c21b891
Public Version Date
September 12, 2022
Public Version Number
5
DI Record Publish Date
July 12, 2019
Package DI Number
34026704631217
Quantity per Package
6
Contains DI Package
14026704631213
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| 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 |