Duns Number:968757448
Device Description: Medivac Guardian 3L v2 Scanning Label and Insert (PN 11032 and PN 11001)
Catalog Number
-
Brand Name
Triton Canister System
Version/Model Number
PN 11033
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
-
Product Code
PBZ
Product Code Name
Image Processing Device For Estimation Of External Blood Loss
Public Device Record Key
391e0f03-261b-4726-85cb-b56a83ba7212
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
February 16, 2018
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 | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 17 |