Duns Number:612770974
Device Description: Pediatric Disposable Probe
Catalog Number
-
Brand Name
Dolphin
Version/Model Number
3312-F
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
Yes
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
K030952
Product Code
DQA
Product Code Name
Oximeter
Public Device Record Key
c2f67ce5-760f-41e0-8d2f-be746af88301
Public Version Date
November 10, 2021
Public Version Number
4
DI Record Publish Date
December 30, 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. | 35 |