Duns Number:825673239
Device Description: AMSure® Pre-Connected Urethral TrayRed Rubber Urethral Catheter Pre-Connected to Drainage AMSure® Pre-Connected Urethral TrayRed Rubber Urethral Catheter Pre-Connected to Drainage Bag.Contents:1200ml Drainage Bag with Pre-Connected 14 Fr Red Rubber Urethral Catheter, CSR Wrap, Waterproof Absorbent Underpad, Pre-Cuffed Nitrile Gloves (2), Fenestrated Drape, Povidone-Iodine Swabsticks (3), Package Sterile Lubricating Jelly, 2oz Specimen Container with ID Label
Catalog Number
AS89214R
Brand Name
AMSure® Pre-Connected Urethral 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
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
9d6d4fdb-af6b-4ec9-9be9-68536a2ea13c
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 23, 2016
Package DI Number
40704411003817
Quantity per Package
20
Contains DI Package
10704411003816
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 |