Duns Number:884718776
Device Description: PRE-CONNECTED FOLEY CATHETER TRAY. CONTENTS: SILICONE COATED LATEX FOLEY CATHETER 16FR, 5C PRE-CONNECTED FOLEY CATHETER TRAY. CONTENTS: SILICONE COATED LATEX FOLEY CATHETER 16FR, 5CC. 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-T165
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
1202735f-83f3-4679-8f98-6b57a73dde96
Public Version Date
December 04, 2020
Public Version Number
5
DI Record Publish Date
February 10, 2017
Package DI Number
40872237005107
Quantity per Package
10
Contains DI Package
00872237005109
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 |