Duns Number:315304071
Device Description: INSUFFLATOR 45 EVAC FR 45L/MIN US version, compatible with core nova, touch screen, color INSUFFLATOR 45 EVAC FR 45L/MIN US version, compatible with core nova, touch screen, color display, with smoke evacuation, U: 100-240VAC, 50/60Hz, Dim. (wxhxd): 300x160x455mm
Catalog Number
2235611
Brand Name
HIGHFLOW
Version/Model Number
2235611
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
-
Product Code
HIF
Product Code Name
INSUFFLATOR, LAPAROSCOPIC
Public Device Record Key
ba3ec351-ab22-4125-b65c-620f3c69f6d4
Public Version Date
April 21, 2021
Public Version Number
4
DI Record Publish Date
July 21, 2017
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 | 587 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1835 |