Duns Number:532396673
Device Description: Cart to be used with Formatk Systems Ltd Forma system (Dsktop) featuring Mobile system
Catalog Number
FS10001
Brand Name
Forma Cart
Version/Model Number
FS10001
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
K160195
Product Code
BZN
Product Code Name
Cart, Emergency, Cardiopulmonary (Excluding Equipment)
Public Device Record Key
7c0a8eee-8dbc-439f-a319-d7cfe8f8a4d6
Public Version Date
July 06, 2018
Public Version Number
4
DI Record Publish Date
August 18, 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 | 5 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 28 |