Duns Number:151772415
Device Description: COMM CABLE,STND,HRM 37P-RAU 8PD,IN-LINE,8FT
Catalog Number
-
Brand Name
COMM CABLE,STND,HRM 37P-RAU 8PD,IN-LINE,8FT
Version/Model Number
AC37F04M0XYY
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
-
Product Code
FNL
Product Code Name
Bed, Ac-Powered Adjustable Hospital
Public Device Record Key
4cdf0f06-bace-4a18-8e86-2ef19f38a6ed
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
August 30, 2017
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 25 |
2 | A medical device with a moderate to high risk that requires special controls. | 792 |