Duns Number:831375089
Device Description: Underpad, Basic Fluff, Light Absorbency, 23" x 36", Light Blue, 10/bg
Catalog Number
6605PP
Brand Name
PremierPro
Version/Model Number
6605PP
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
KME
Product Code Name
Bedding, Disposable, Medical
Public Device Record Key
c865b01f-d8fa-4c5d-8334-0aac9282ccdb
Public Version Date
February 21, 2022
Public Version Number
2
DI Record Publish Date
September 08, 2020
Package DI Number
10811220030015
Quantity per Package
15
Contains DI Package
00811220030018
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 | 486 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 177 |
| U | Unclassified | 1 |