Duns Number:106908437
Device Description: 7Day,Sterile,TapFilter,w/ SprayOutlet (1)
Catalog Number
-
Brand Name
MICROTEK
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)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K173164,K173164,K173164
Product Code
NHV
Product Code Name
SYSTEM, WATER PURIFICATION, GENERAL MEDICAL USE
Public Device Record Key
e59f96ca-161b-4455-a0b0-457006f5e8de
Public Version Date
October 01, 2018
Public Version Number
1
DI Record Publish Date
August 29, 2018
Package DI Number
18425921000592
Quantity per Package
10
Contains DI Package
08425921000595
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 919 |