Duns Number:021899778
Catalog Number
714-A
Brand Name
714-A iCrib
Version/Model Number
714-A
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
-
Product Code
FNL
Product Code Name
Bed, Ac-Powered Adjustable Hospital
Public Device Record Key
564160d0-7900-415f-9c58-6c1f667989fd
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
March 17, 2017
Package DI Number
00852231007842
Quantity per Package
1
Contains DI Package
00852231007835
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 63 |