Duns Number:126830020
Device Description: Aquavage 2000cc
Catalog Number
AV2000D
Brand Name
MD Resource
Version/Model Number
AV2000D
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
K092284,K092284,K092284,K092284,K092284,K092284,K092284
Product Code
KYZ
Product Code Name
Syringe, Irrigating (Non Dental)
Public Device Record Key
63377458-11c0-447f-97c7-791dbfc58fc2
Public Version Date
January 08, 2021
Public Version Number
7
DI Record Publish Date
September 08, 2016
Package DI Number
70859898006408
Quantity per Package
10
Contains DI Package
00859898006409
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. | 12 |