Duns Number:533108028
Device Description: Sapphire Power Supply (fixed head) with plastic ODU connector
Catalog Number
15072-000-0007-ASM
Brand Name
Sapphire Power Supply (fixed head)
Version/Model Number
15072-000-0007-ASM
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
June 29, 2017
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K123049,K123049,K123049
Product Code
MRZ
Product Code Name
Accessories, Pump, Infusion
Public Device Record Key
feaa9a06-1c9e-499a-8476-599cb5310b77
Public Version Date
July 22, 2021
Public Version Number
4
DI Record Publish Date
September 01, 2016
Package DI Number
27290109150059
Quantity per Package
50
Contains DI Package
17290109150052
Package Discontinue Date
June 29, 2017
Package Status
Not 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 |