Duns Number:627879687
Device Description: Inline Tubing Set for Use with Pentax Endoscopes is a CO2 Endoscopic Insufflator Inline T Inline Tubing Set for Use with Pentax Endoscopes is a CO2 Endoscopic Insufflator Inline Tubing Set intended to connect a CO2 source (insufflator) and a sterile water source (water bottle) to an endoscope to supply CO2 during gastrointestinal endoscopic procedures.
Catalog Number
710425
Brand Name
NA
Version/Model Number
710425
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
FCX
Product Code Name
INSUFFLATOR, AUTOMATIC CARBON-DIOXIDE FOR ENDOSCOPE
Public Device Record Key
a1d02731-754b-4e34-b2c0-babfbc66813a
Public Version Date
June 10, 2022
Public Version Number
5
DI Record Publish Date
April 02, 2020
Package DI Number
10724995180413
Quantity per Package
24
Contains DI Package
00724995180416
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| 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 |