Duns Number:830016148
Device Description: 3M™ Ranger™ Pressure Infusor, 14500, Model 145, 120V-ENG-B, 1 Each
Catalog Number
14500
Brand Name
3M™ Ranger™
Version/Model Number
14500
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
KZD
Product Code Name
INFUSOR, PRESSURE, FOR I.V. BAGS
Public Device Record Key
cc47e838-d301-4da9-b73b-44831edbd5a8
Public Version Date
March 18, 2021
Public Version Number
1
DI Record Publish Date
March 10, 2021
Package DI Number
50707387802948
Quantity per Package
1
Contains DI Package
00707387802943
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 | 274 |
2 | A medical device with a moderate to high risk that requires special controls. | 444 |
U | Unclassified | 7 |