Duns Number:867673159
Device Description: RespiratoryPulse Oximeters Product Description: View Sp02 Fingertip Pulse Oximeter 1/ea
Catalog Number
-
Brand Name
Medquip
Version/Model Number
MQ3200
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
OCH
Product Code Name
oximeter, infrared, sporting, aviation
Public Device Record Key
8233f21f-52f7-4179-a31d-b079057e5753
Public Version Date
February 03, 2021
Public Version Number
3
DI Record Publish Date
June 21, 2019
Package DI Number
10705105532360
Quantity per Package
10
Contains DI Package
00705105532363
Package Discontinue Date
June 21, 2019
Package Status
Not in Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 3783 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 832 |