Duns Number:825673239
Device Description: AMSure® Add-A-Foley Catheter TrayCONTENTS;1 2000mL Drainage bag, 1 Wrap, 1 Drape, 2 Nitril AMSure® Add-A-Foley Catheter TrayCONTENTS;1 2000mL Drainage bag, 1 Wrap, 1 Drape, 2 Nitrile Gloves, 1 Fenestrate Drape, 1 Pkg. Povidone-Iodine Solution, 5 Rayon Balls, 1 Catheter Lubricating Jelly Sachet, 1 Plastic Forceps, 1 Specimen Container and Label, 1 10mL Syringe with Pre-filled Sterile Water
Catalog Number
AS89300
Brand Name
AMSure® Add-A-Foley Catheter Tray
Version/Model Number
1
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FCM
Product Code Name
Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)
Public Device Record Key
083d28f1-9ca1-4164-8d37-c0cb59eb95f8
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 23, 2016
Package DI Number
40704411005293
Quantity per Package
10
Contains DI Package
10704411005292
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 89 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 411 |
| U | Unclassified | 1 |