Duns Number:068014556
Device Description: Convenience tray for the Macy Catheter. Contents include: Macy Catheter, 60ml Enteral/Oral Convenience tray for the Macy Catheter. Contents include: Macy Catheter, 60ml Enteral/Oral Syringe, 10ml Enteral/Oral Syringe, 3ml Enteral/Oral Syringe, (2) 10ml Pre-filled Balloon Inflation Syringes, Macy Catheter Instructions for Use, 3-Ply Poly Towel, Nitrile Gloves, Lubricating Jelly, Catheter Securing Device.
Catalog Number
MCT-1001
Brand Name
Macy Catheter Tray
Version/Model Number
B
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"
-
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
KDD
Product Code Name
Kit, Surgical Instrument, Disposable
Public Device Record Key
b8dd44d5-2a83-4fb3-a525-59252f6928f9
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
May 13, 2016
Package DI Number
10861003000223
Quantity per Package
10
Contains DI Package
00861003000226
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |