Duns Number:083211284
Device Description: TWO BULB ARRAY
Catalog Number
-
Brand Name
n/a
Version/Model Number
7181-9800
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
K954798
Product Code
KLA
Product Code Name
Monitor, Esophageal Motility, And Tube
Public Device Record Key
aa7ae293-2a4c-4172-9f92-a6b5cce17067
Public Version Date
November 08, 2019
Public Version Number
5
DI Record Publish Date
April 05, 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 | 247 |
2 | A medical device with a moderate to high risk that requires special controls. | 425 |