Duns Number:008124539
Device Description: Disposable Underpads, 30x36 (90g) with Polymer
Catalog Number
-
Brand Name
Disposable Underpads
Version/Model Number
1348
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Safe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
Yes
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
76542781-1d83-4d52-bdd5-d2ccfeefdc1b
Public Version Date
February 21, 2022
Public Version Number
2
DI Record Publish Date
September 01, 2021
Package DI Number
00616784134833
Quantity per Package
2
Contains DI Package
00616784134826
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 | 694 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 226 |
| 3 | A medical device with high risk that requires premarket approval | 2 |