Duns Number:533108028
Catalog Number
17000-026-0007
Brand Name
Mini Cradle with Splitter- US
Version/Model Number
17000-026-0007
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)
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,K123049
Product Code
MRZ
Product Code Name
Accessories, Pump, Infusion
Public Device Record Key
19c0e6c2-5b20-4692-87f3-79fe92d76423
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
October 23, 2016
Package DI Number
27290109150110
Quantity per Package
20
Contains DI Package
17290109150113
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 |