Duns Number:161989343
Device Description: Part Number 108110-US, Power Cord: Hospital US
Catalog Number
108110-US
Brand Name
VTI Power Cord: Hospital US
Version/Model Number
108110-US
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
K082870
Product Code
DPW
Product Code Name
FLOWMETER, BLOOD, CARDIOVASCULAR
Public Device Record Key
1b99902f-6883-426d-8d5e-323d39606d7b
Public Version Date
April 07, 2021
Public Version Number
4
DI Record Publish Date
September 20, 2016
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 |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 28 |