Duns Number:013649151
Device Description: Non-MRI, USB strip-chart printer for the Expression Information Portal. Includes printer w Non-MRI, USB strip-chart printer for the Expression Information Portal. Includes printer with USB cable and power adapter
Catalog Number
989803181881
Brand Name
MR Patient Care Thermal Printer Kit, USB
Version/Model Number
Printer Kit, Strip Chart, USB
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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
DSF
Product Code Name
Recorder, Paper Chart
Public Device Record Key
306957aa-9a7b-400c-be0a-5092ed0c90cc
Public Version Date
March 01, 2022
Public Version Number
1
DI Record Publish Date
February 21, 2022
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 | 17 |
2 | A medical device with a moderate to high risk that requires special controls. | 650 |
U | Unclassified | 4 |