Duns Number:108999095
Device Description: DIAGNOSTIX Pulse Oximeter,Fingertip, Adult
Catalog Number
2100
Brand Name
Diagnostix™
Version/Model Number
2100
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
K101577,K101577,K101577
Product Code
DQA
Product Code Name
Oximeter
Public Device Record Key
b9743388-2b33-45ed-ba30-7255bf91585c
Public Version Date
November 10, 2021
Public Version Number
6
DI Record Publish Date
September 21, 2016
Package DI Number
00634782561888
Quantity per Package
25
Contains DI Package
00634782861889
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Master Case
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 2395 |
2 | A medical device with a moderate to high risk that requires special controls. | 1769 |