Duns Number:008124539
Device Description: Non-Woven Fitted Cot Sheet With Elastic Ends, White, 33" x 89" (84cm x 226cm)
Catalog Number
-
Brand Name
Non-Woven Fitted Cot Sheet
Version/Model Number
3509
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)
-
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
505dc64f-7879-4b03-9050-9225bf07f890
Public Version Date
May 03, 2022
Public Version Number
1
DI Record Publish Date
April 25, 2022
Package DI Number
00616784350936
Quantity per Package
50
Contains DI Package
00616784350912
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 |