Duns Number:021717889
Device Description: Irrigation Tubing System
Catalog Number
SIT-575
Brand Name
Hydra
Version/Model Number
SIT-575
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FEQ
Product Code Name
PUMP, AIR, NON-MANUAL, FOR ENDOSCOPE
Public Device Record Key
f94d7832-5aaf-4c4d-901a-9ad64721db62
Public Version Date
June 10, 2022
Public Version Number
3
DI Record Publish Date
October 08, 2020
Package DI Number
00840253108425
Quantity per Package
15
Contains DI Package
00840253108418
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 | 536 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8659 |
| 3 | A medical device with high risk that requires premarket approval | 1821 |
| U | Unclassified | 35 |