Duns Number:790605856
Device Description: Foley Catheter Temperature Probe Disposable; size = 16Fr; probe length = 17" (43cm); steri Foley Catheter Temperature Probe Disposable; size = 16Fr; probe length = 17" (43cm); sterile; minimum shelf life = 12 months; 1cs = 10 probes; wgt = 1lb (454g)
Catalog Number
21096A
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
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"
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
585d3911-4930-457d-9b50-e4109dcc5cf3
Public Version Date
September 16, 2022
Public Version Number
7
DI Record Publish Date
December 07, 2016
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 |