Duns Number:047025993
Device Description: Pulse Oximeter White
Catalog Number
-
Brand Name
Vive Presicion
Version/Model Number
DMD1028WHT
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
July 26, 2020
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)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
DQA
Product Code Name
Oximeter
Public Device Record Key
27948e10-7dec-471b-b6f6-c8ca4f163a41
Public Version Date
November 10, 2021
Public Version Number
6
DI Record Publish Date
November 15, 2017
Package DI Number
20818323021596
Quantity per Package
100
Contains DI Package
10818323021599
Package Discontinue Date
July 26, 2020
Package Status
Not 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 | 480 |
2 | A medical device with a moderate to high risk that requires special controls. | 87 |