Duns Number:627879687
Device Description: The High Pressure Hose and Yoke for CO2 for use with US Endoscopy CO2 Insufflators in conj The High Pressure Hose and Yoke for CO2 for use with US Endoscopy CO2 Insufflators in conjunction with medical grade CO2 cylinders with standard yoke connectors.
Catalog Number
710603
Brand Name
NA
Version/Model Number
710603
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
March 31, 2020
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
K111648
Product Code
FCX
Product Code Name
INSUFFLATOR, AUTOMATIC CARBON-DIOXIDE FOR ENDOSCOPE
Public Device Record Key
301ae9ae-bad8-434e-9dea-ced4ab6758f4
Public Version Date
July 04, 2022
Public Version Number
5
DI Record Publish Date
September 17, 2016
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 | 51 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 902 |