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 is for use with compatible pulse oximeters. These include: Nellcor OxiMax and Oxisensor II compatible monitors and Philips FAST compatible monitors.
Catalog Number
-
Brand Name
Nasal Alar Sp02 Sensor
Version/Model Number
0303
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
2cea16fd-551b-46df-9dd5-61fd45925834
Public Version Date
November 10, 2021
Public Version Number
3
DI Record Publish Date
February 11, 2017
Package DI Number
B21303031
Quantity per Package
24
Contains DI Package
B21303030
Package Discontinue Date
-
Package Status
-
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |