Duns Number:783518983
Device Description: Non- Invasive measurement of arterial blood oxygen saturation and pulse rate.
Catalog Number
-
Brand Name
Pro Comfort Pulse Oximeter
Version/Model Number
C101B1
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Safe
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
K173123,K173123
Product Code
DQA
Product Code Name
Oximeter
Public Device Record Key
e882a83c-a427-4a0c-89f4-ed3257b3b00b
Public Version Date
November 10, 2021
Public Version Number
2
DI Record Publish Date
March 13, 2020
Package DI Number
10850632007536
Quantity per Package
200
Contains DI Package
00850632007539
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 24 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 44 |
| U | Unclassified | 11 |