Duns Number:013112308
Device Description: FOLEY CATHETER, 2 WAY 14FR, 15 ML, EA. LATEX, SILICONE COATED RUBBER VALVE.
Catalog Number
AMP112214
Brand Name
Rospital Productos Medicos
Version/Model Number
AMP112214
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)
Yes
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
K082815,K082815,K082815
Product Code
EZL
Product Code Name
Catheter, Retention Type, Balloon
Public Device Record Key
6d1433d3-9a22-4c16-bfb5-0d791210e7c7
Public Version Date
December 04, 2020
Public Version Number
2
DI Record Publish Date
June 13, 2020
Package DI Number
10812460027735
Quantity per Package
10
Contains DI Package
00812460027738
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
INNER
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 17 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 7 |