Duns Number:031138244
Device Description: The Assurance® Nasal Alar SpO2™ Sensor is indicated for single patient use for continuous The Assurance® Nasal Alar SpO2™ Sensor is indicated for single patient use for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate from the nasal ala of adult and pediatric patients, (weighing > 30kg). The sensor can be used in a variety of healthcare environments where compatible pulse oximetry monitors are indicated for use, under professional supervision.The Assurance® Nasal Alar SpO2™ Sensor (REF 0201-A01) is for use with Philips FAST SpO2 compatible monitors.
Catalog Number
-
Brand Name
Nasal Alar Sp02 Sensor
Version/Model Number
0201-A01
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
MRI safety Status
MR Unsafe
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"
Yes
For Single-Use
Yes
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
-
Product Code
DQA
Product Code Name
Oximeter
Public Device Record Key
c4ca9764-3bf9-4e03-9ccf-0ecbe36a640f
Public Version Date
November 10, 2021
Public Version Number
2
DI Record Publish Date
March 09, 2018
Package DI Number
B2130201A012
Quantity per Package
6
Contains DI Package
B2130201A011
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Shipping Carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |