Duns Number:042823948
Device Description: Check-Flo Adapter
Catalog Number
050885
Brand Name
Check-Flo
Version/Model Number
G15476
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
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
ODC
Product Code Name
Endoscope channel accessory
Public Device Record Key
9f89c1cd-f1d0-45ed-94ef-f3a4c4662f98
Public Version Date
March 27, 2020
Public Version Number
4
DI Record Publish Date
September 24, 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 | 669 |
2 | A medical device with a moderate to high risk that requires special controls. | 8328 |
3 | A medical device with high risk that requires premarket approval | 370 |
U | Unclassified | 242 |