Duns Number:825673239
Device Description: 400mL Urine Meter attached to 2600mL Drainage Bag (China) with: Universal hook hangerBed s 400mL Urine Meter attached to 2600mL Drainage Bag (China) with: Universal hook hangerBed sheet clampT-valve drainage outletAir ventAMSafe® needleless sampling port10 mL Pre-Filled Syringe with Sterile Water (China)
Catalog Number
AS89800
Brand Name
AMSure ® Add-A-Foley 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)
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
-
Product Code
FCM
Product Code Name
Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)
Public Device Record Key
09295006-1b80-48eb-aa80-b284b6585456
Public Version Date
April 06, 2022
Public Version Number
1
DI Record Publish Date
March 29, 2022
Package DI Number
40704411014882
Quantity per Package
10
Contains DI Package
10704411014881
Package Discontinue Date
March 08, 2022
Package Status
Not 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 |