Duns Number:809699023
Device Description: NAMIC Perceptor DT Disposable Transducer 24" (61 cm) Transducer with Pigtail Cable
Catalog Number
-
Brand Name
NAMIC
Version/Model Number
80030013
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
Yes
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
K910764,K910764
Product Code
DRS
Product Code Name
Transducer, blood-pressure, extravascular
Public Device Record Key
70975f15-3de6-441f-96e0-cf482fba12ed
Public Version Date
December 03, 2019
Public Version Number
2
DI Record Publish Date
September 16, 2019
Package DI Number
H965800300131
Quantity per Package
50
Contains DI Package
H965800300130
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 71 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1641 |