Duns Number:068014556
Device Description: Convenience kit for the Macy Catheter.Contents include: Macy Catheter, Liqui-Pill Assembly Convenience kit for the Macy Catheter.Contents include: Macy Catheter, Liqui-Pill Assembly, Water Reservoir Assembly, 20ml Luer Lock Syringe, 3ml Exteral/Oral Syringe, 10ml Enteral/Oral Syringe, Macy Catheter Instructions for Use, Macy Catheter Bedside Care Kit Manual, Macy Catheter Medication Sheet (2), 3-Ply Poly Towel, Lubricating Jelly, Nitrile Gloves, Catheter Securing Device.
Catalog Number
MCK-1001
Brand Name
Macy Catheter Bedside Care Kit
Version/Model Number
D
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
0fec0a00-7451-4db3-a8c4-667993518869
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
May 20, 2016
Package DI Number
10861003000216
Quantity per Package
10
Contains DI Package
00861003000219
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 |