Duns Number:007153505
Device Description: DETECTO Whisper Series ER Medical Cart, 5 Red Drawers
Catalog Number
-
Brand Name
Detecto
Version/Model Number
WC33669RED
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)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
BZN
Product Code Name
Cart, Emergency, Cardiopulmonary (Excluding Equipment)
Public Device Record Key
5c0ce78d-bee7-425a-8ef9-695d92200b7e
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
August 21, 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 | 252 |