Duns Number:030650113
Device Description: Air/Water Cleaning Adapter for Olympus® GI Endoscope
Catalog Number
1203-60
Brand Name
BullDog®
Version/Model Number
1203-60
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
Yes
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
FFY
Product Code Name
Adaptor, Bulbs, Miscellaneous, For Endoscope
Public Device Record Key
32434786-1efd-4be9-8bb4-faab5eb57e17
Public Version Date
November 02, 2020
Public Version Number
1
DI Record Publish Date
October 23, 2020
Package DI Number
10816734022785
Quantity per Package
100
Contains DI Package
00816734022788
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 | 109 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 207 |