Duns Number:255343022
Device Description: A reusable high level disinfectant solution designed to be used with heat sensitive medica A reusable high level disinfectant solution designed to be used with heat sensitive medical devices and instruments, for which heat sterilization is not suitable.
Catalog Number
25505
Brand Name
Prevention
Version/Model Number
HLD8 High Level Disinfectant
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
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K091022,K091022
Product Code
MED
Product Code Name
Sterilant, Medical Devices
Public Device Record Key
0f59f432-d281-4460-9832-9075af5a076e
Public Version Date
September 29, 2021
Public Version Number
7
DI Record Publish Date
August 01, 2017
Package DI Number
10068460505197
Quantity per Package
4
Contains DI Package
00068460505190
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 36 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |