Duns Number:145581588
Device Description: HL7 VITAL SIGNS INTERFACE,92843
Catalog Number
V5.2.3
Brand Name
Intesys Clinical Suite
Version/Model Number
92843
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
August 17, 2018
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
OUG
Product Code Name
Medical device data system
Public Device Record Key
f8370e29-ba64-497b-bc9e-9aaab3729891
Public Version Date
November 08, 2018
Public Version Number
5
DI Record Publish Date
September 22, 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 | 18 |
2 | A medical device with a moderate to high risk that requires special controls. | 732 |