Duns Number:022925151
Device Description: Disposable Underpads 34”x22” Incontinence Bed Covers Pads Pet Training Ultra Thick Super A Disposable Underpads 34”x22” Incontinence Bed Covers Pads Pet Training Ultra Thick Super Absorbent & Waterproof Protection Box of 20
Catalog Number
-
Brand Name
P&P Medical Surgical LLC
Version/Model Number
05000
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
MRI safety Status
MR Safe
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"
-
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
ed0394f3-40a1-477f-9e1f-c3788b0728b7
Public Version Date
February 21, 2022
Public Version Number
2
DI Record Publish Date
February 10, 2022
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 53 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 4 |