Duns Number:079389709
Device Description: SPO55 Pulse Oximeter intended for wellness use in measuring the blood oxygen saturation an SPO55 Pulse Oximeter intended for wellness use in measuring the blood oxygen saturation and the heart rate (pulse rate).
Catalog Number
454.12
Brand Name
Silvercrest
Version/Model Number
IAN 387871_2101
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)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
PGJ
Product Code Name
Oximeter, Wellness
Public Device Record Key
5ea16284-465b-4747-af87-bf4c5a98659c
Public Version Date
November 10, 2021
Public Version Number
2
DI Record Publish Date
August 30, 2021
Package DI Number
14055334330401
Quantity per Package
4
Contains DI Package
04055334330404
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case pack
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 11 |