Duns Number:081057389
Device Description: Pillowcase, Blue
Catalog Number
67803
Brand Name
Halyard
Version/Model Number
67803
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
-
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
0e74686f-47d5-489d-a8dd-6bd9c84931f7
Public Version Date
July 04, 2022
Public Version Number
2
DI Record Publish Date
December 31, 2020
Package DI Number
30680651678035
Quantity per Package
1
Contains DI Package
20680651678038
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CS
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. | 1044 |