Duns Number:556196210
Device Description: CONFIGURATION, DUAL PATIENT LITTER SYSTEM (DPLS)
Catalog Number
-
Brand Name
Dual Patient Litter System (DPLS)
Version/Model Number
15-00268-01-P01-A01
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
FOX
Product Code Name
Stand, Infusion
Public Device Record Key
a4d15bfc-fb05-47b4-af56-5bf516b0b82e
Public Version Date
May 19, 2021
Public Version Number
1
DI Record Publish Date
May 11, 2021
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 | 213 |
2 | A medical device with a moderate to high risk that requires special controls. | 6 |