Duns Number:556196210
Device Description: ASSEMBLY – MEDPAK
Catalog Number
-
Brand Name
MedPak
Version/Model Number
MP2-001-05
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
BXO
Product Code Name
Transducer, Gas Pressure
Public Device Record Key
9a11a8e0-7159-4f94-81d4-a63b48ad2049
Public Version Date
November 05, 2021
Public Version Number
1
DI Record Publish Date
October 28, 2021
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 | 213 |
2 | A medical device with a moderate to high risk that requires special controls. | 6 |