Duns Number:240992693
Device Description: MED-RX Insufflation Filter Set
Catalog Number
10-1356
Brand Name
MED-RX
Version/Model Number
10-1356
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
NKC
Product Code Name
Tubing/Tubing With Filter, Insufflation, Laparoscopic
Public Device Record Key
657aca22-b28d-4985-83dc-94007ac10211
Public Version Date
June 10, 2022
Public Version Number
3
DI Record Publish Date
December 20, 2019
Package DI Number
50628725003493
Quantity per Package
20
Contains DI Package
00628725003498
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
carton
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 19 |
2 | A medical device with a moderate to high risk that requires special controls. | 15 |