Duns Number:783518983
Device Description: • 150 underpads per box• Size: 30in x 36in• 28" wide pad• 60 grams of padding• 24" of • 150 underpads per box• Size: 30in x 36in• 28" wide pad• 60 grams of padding• 24" of padded protection• Extra absorbent underpads for incontinence• Provides excellent protection for beds and chairs• Absorbs well to prevent leakage• Reduces odors and maintains dryness
Catalog Number
-
Brand Name
Comfort Shield Adult Underpads
Version/Model Number
1539
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"
-
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
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
44e86b80-ff45-4874-b48b-200c96c7ec97
Public Version Date
June 17, 2022
Public Version Number
3
DI Record Publish Date
July 18, 2018
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 | 24 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 44 |
| U | Unclassified | 11 |