Duns Number:206449154
Device Description: Fingertip Pulse Oximeter is a portable non-invasive, spot-check, oxygen saturation of arte Fingertip Pulse Oximeter is a portable non-invasive, spot-check, oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of adult and pediatric patient at home, and hospital (including clinical use and in internist/surgery, Anesthesia, intensive care and etc.). Not for continuously monitoring.
Catalog Number
01MN1000
Brand Name
Fingertip Pulse Oximeter
Version/Model Number
01MN1000
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K070371,K070371
Product Code
DQA
Product Code Name
Oximeter
Public Device Record Key
aed30418-1752-498e-8e62-deff527ac2b1
Public Version Date
November 10, 2021
Public Version Number
4
DI Record Publish Date
September 23, 2016
Package DI Number
17540195054001
Quantity per Package
15
Contains DI Package
07540195054004
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Pouch and Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 32 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 48 |
| U | Unclassified | 3 |