Duns Number:367919120
Device Description: Foley Catheter with Temperature Probe, Disposable, 14 Fr
Catalog Number
M1024239
Brand Name
N/A
Version/Model Number
M1024239
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
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
-
Product Code
EYC
Product Code Name
CATHETER, UPPER URINARY TRACT
Public Device Record Key
c9d3932b-97a8-461e-8d06-b869d99cdf0a
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 14, 2016
Package DI Number
70885403251315
Quantity per Package
25
Contains DI Package
10885403251313
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Pack
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 363 |