Duns Number:200103823
Device Description: Rescuer MVP Manual Vacuum Pump with Collection jar and two oral suction catheters
Catalog Number
7000-MVP
Brand Name
Rescuer MVP Manual Vacuum Pump
Version/Model Number
7000-MVP
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
-
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
OFO
Product Code Name
Airway Suction Kit
Public Device Record Key
61a1d355-3a39-4c40-9ac4-269b63d4f98f
Public Version Date
November 02, 2018
Public Version Number
1
DI Record Publish Date
October 02, 2018
Package DI Number
B0027000MVP4
Quantity per Package
20
Contains DI Package
B0027000MVP0
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 | 15 |
2 | A medical device with a moderate to high risk that requires special controls. | 32 |