Duns Number:825673239
Device Description: AMSure® Pre-Connected Urethral Tray14 Fr. Red Rubber Urethral Catheter Pre-Connected to Dr AMSure® Pre-Connected Urethral Tray14 Fr. Red Rubber Urethral Catheter Pre-Connected to Drainage Bag1 each 1200 mL Drainage Bag with Pre-Connected 14 Fr. Red Rubber Urethral CatheterCONTENTS STERILIZED USING ETHYLENE OXIDE:1 each CSR Wrap1 each Waterproof Absorbent Underpad1 pair Pre-Cuffed Nitrile Gloves1 each Fenestrated Drape1 pack Package Sterile Lubricating Jelly1 each 2 oz Specimen Container with ID LabelNON-STERILE CONTENT:1 pack BZK Swabsticks (3)
Catalog Number
AS89214K
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
3ba81143-1c33-4b31-985f-9e20299a4e90
Public Version Date
May 29, 2018
Public Version Number
1
DI Record Publish Date
April 28, 2018
Package DI Number
40704411007549
Quantity per Package
20
Contains DI Package
10704411007548
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 |