Duns Number:825673239
Device Description: AMSure® Foley Insertion TrayCONTENTS STERILIZEDUSING ETHYLENE OXIDE:1 each 1000 mL Outer B AMSure® Foley Insertion TrayCONTENTS STERILIZEDUSING ETHYLENE OXIDE:1 each 1000 mL Outer Basin Tray1 each Prefilled 10 mL Syringe of Sterile Water1 pair Vinyl Gloves1 each Waterproof Drape1 each Fenestrated Drape1 pack Lubricating JellyNON-STERILE CONTENT:1 pack BZK Swabsticks (3)
Catalog Number
AS880K
Brand Name
AMSure® Foley Insertion 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
-
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
dd282bec-c97e-472b-9ee9-1302565f1725
Public Version Date
May 29, 2018
Public Version Number
1
DI Record Publish Date
April 28, 2018
Package DI Number
40704411007617
Quantity per Package
20
Contains DI Package
10704411007616
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 |