Duns Number:827221698
Device Description: Roscoe Respire Fingertip Pulse Oximeter, Black
Catalog Number
-
Brand Name
Roscoe Medical
Version/Model Number
POX-RSPBK
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
b4104976-f0a9-4ddb-a334-2dc84b781823
Public Version Date
November 10, 2021
Public Version Number
2
DI Record Publish Date
June 03, 2020
Package DI Number
30092237622392
Quantity per Package
200
Contains DI Package
00092237622391
Package Discontinue Date
-
Package Status
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 | 62 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 273 |
| U | Unclassified | 2 |