Duns Number:790605856
Device Description: Foley Catheter Temperature Probe Disposable; size = 14Fr; probe length = 17" (43cm); steri Foley Catheter Temperature Probe Disposable; size = 14Fr; probe length = 17" (43cm); sterile; minimum shelf life = 12 months; 1 cs = 10 probes; wgt = 1 lb (454g)
Catalog Number
M2255A
Brand Name
Temperature Probes
Version/Model Number
Foley Catheter Temperature Probe
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"
Yes
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
EZL
Product Code Name
CATHETER, RETENTION TYPE, BALLOON
Public Device Record Key
67ac454c-1b36-4e79-a1ff-96e0a1988e55
Public Version Date
September 21, 2022
Public Version Number
7
DI Record Publish Date
November 01, 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 | 7 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 323 |
| 3 | A medical device with high risk that requires premarket approval | 36 |
| U | Unclassified | 1 |