Duns Number:533108028
Catalog Number
15072-000-0007
Brand Name
Sapphire Power Supply
Version/Model Number
15072-000-0007
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
K192860,K192860,K192860
Product Code
MRZ
Product Code Name
Accessories, Pump, Infusion
Public Device Record Key
07f1f86a-124b-4dfc-be0f-289650497239
Public Version Date
May 23, 2022
Public Version Number
1
DI Record Publish Date
May 15, 2022
Package DI Number
27290109154316
Quantity per Package
10
Contains DI Package
17290109154319
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Cardboard box
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 65 |