Duns Number:533108028
Catalog Number
05040-300-0011
Brand Name
Mini Cradle
Version/Model Number
05040-300-0011
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"
Yes
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
362838d2-092d-4aa4-b352-85732d9f137b
Public Version Date
May 23, 2022
Public Version Number
1
DI Record Publish Date
May 15, 2022
Package DI Number
27290109154033
Quantity per Package
20
Contains DI Package
17290109154036
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 |