Duns Number:080361159
Device Description: UNDERPAD 40" * 57"
Catalog Number
-
Brand Name
PRIMO/ASP MEDICAL
Version/Model Number
UPA4057
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)
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
3c438715-298c-4582-ad0b-77325003a709
Public Version Date
August 23, 2022
Public Version Number
1
DI Record Publish Date
August 15, 2022
Package DI Number
00840216118355
Quantity per Package
25
Contains DI Package
00840216117662
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 | 1046 |
2 | A medical device with a moderate to high risk that requires special controls. | 23 |
U | Unclassified | 2 |