Duns Number:362187580
Device Description: UNIVERSAL PILLOW CASE, 21" x 30", WHITE
Catalog Number
PL100
Brand Name
AllCare
Version/Model Number
PL100
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)
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
d13dc585-8aab-43f7-8628-2c06ed6b7fe9
Public Version Date
July 04, 2022
Public Version Number
2
DI Record Publish Date
April 06, 2022
Package DI Number
10182921000493
Quantity per Package
100
Contains DI Package
00182921000496
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 | 20 |