Duns Number:279456896
Device Description: The support for suction pockets is an accessory which can be attached to the shaft of the The support for suction pockets is an accessory which can be attached to the shaft of the HYGITECH infusion stand.It offers an ideal medium for a suction waste pouches. Made of stainless steel AISI 304 18/10 black anodised.Inner Diameter: 30 cmHeight Adjustable2 Year Warranty
Catalog Number
HY-90078
Brand Name
HYGITECH
Version/Model Number
HY-90078
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"
Yes
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
-
Product Code
KDQ
Product Code Name
Bottle, Collection, Vacuum
Public Device Record Key
083519ee-45ce-4440-aa72-d5f1c3d5e029
Public Version Date
December 22, 2020
Public Version Number
1
DI Record Publish Date
December 14, 2020
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 87 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8 |