Duns Number:068199363
Device Description: ENDOGATOR Tubing for BOSTON SCIENTIFIC ENDOSTAT II Pump, OLYMPUS OFP Pump or ENDO STRATUS ENDOGATOR Tubing for BOSTON SCIENTIFIC ENDOSTAT II Pump, OLYMPUS OFP Pump or ENDO STRATUS Pump
Catalog Number
100130
Brand Name
ENDOGATOR
Version/Model Number
100130
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
K220395,K033695,K220395,K033695,K220395,K033695
Product Code
FEQ
Product Code Name
PUMP, AIR, NON-MANUAL, FOR ENDOSCOPE
Public Device Record Key
0ac67e5f-7210-4e7a-824c-702b87e19c5d
Public Version Date
May 11, 2022
Public Version Number
10
DI Record Publish Date
September 22, 2016
Package DI Number
20677964058466
Quantity per Package
50
Contains DI Package
00677964058462
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 2999 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 362 |