Duns Number:002348191
Device Description: PLEUR-EVAC INFANT DRY/WET LATEX FREE
Catalog Number
A-6020-08LF
Brand Name
PLEUR-EVAC
Version/Model Number
IPN028444
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
K905768,K905768,K905768,K905768
Product Code
KDQ
Product Code Name
BOTTLE, COLLECTION, VACUUM
Public Device Record Key
91517832-3515-444b-be24-5a0b84382cb1
Public Version Date
January 20, 2021
Public Version Number
3
DI Record Publish Date
July 12, 2019
Package DI Number
44026704631252
Quantity per Package
6
Contains DI Package
34026704631255
Package Discontinue Date
-
Package Status
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 |