Duns Number:884718776
Device Description: UNIVERSAL CATHETERIZATION TRAY. CONTENTS: DRAINAGE BAG 2000CC, SYRINGE 10CC PRE-FILLED W/ UNIVERSAL CATHETERIZATION TRAY. CONTENTS: DRAINAGE BAG 2000CC, SYRINGE 10CC PRE-FILLED W/ STERILE WATER, COTTON BALLS (6), VINYL GLOVES (2), DRAPE, FENESTRATED DRAPE, CATHETER LUBRICATING JELLY, POVIDONE-IODINE SOLUTION, SPECIMEN CONTAINER 2oz, PATIENT LABEL, FORCEPS, WRAP.
Catalog Number
-
Brand Name
GLOBAL HEALTHCARE
Version/Model Number
60-T01
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
94fec1fc-9045-4e88-ac58-d47b83f260a3
Public Version Date
December 04, 2020
Public Version Number
5
DI Record Publish Date
February 10, 2017
Package DI Number
40872237005244
Quantity per Package
10
Contains DI Package
00872237005246
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CASE
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 62 |