Duns Number:098308849
Device Description: ACCY PC140 MIDAS REX FN2 DISS F SCHRADER
Catalog Number
-
Brand Name
Midas Rex
Version/Model Number
PC140
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
K020069
Product Code
CAN
Product Code Name
REGULATOR, PRESSURE, GAS CYLINDER
Public Device Record Key
43424f2e-ac37-45c3-ab88-157e1632f592
Public Version Date
July 04, 2022
Public Version Number
3
DI Record Publish Date
October 02, 2020
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 | 450 |
2 | A medical device with a moderate to high risk that requires special controls. | 3534 |