Duns Number:181184474
Device Description: CB10639 - Pulse Oximeter Adapter Cable
Catalog Number
CB10639
Brand Name
AIV
Version/Model Number
CB10639
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
September 24, 2019
Issuing Agency
In HIBCC
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
DQA
Product Code Name
Oximeter
Public Device Record Key
14f4a677-c617-4cfc-8639-9f44528f9c16
Public Version Date
November 10, 2021
Public Version Number
5
DI Record Publish Date
September 02, 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. | 24 |