FDA.reportPublic FDA data

Nasal Alar Sp02 Sensor

Primary DI
B2130201A010
Brand
Nasal Alar Sp02 Sensor
Company
XHALE ASSURANCE, INC.
Model
0201-A01
Device description
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.
Published
2018-03-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
DQAOximeter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQAOximeterCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B2130201A011PackageHIBCC20In Commercial Distribution
B2130201A012PackageHIBCC6In Commercial Distribution
B2130201A010PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Pulse oximeter probe, single-useA photoelectric device designed to be applied externally to a body site (e.g., fingertip, ear lobe, bridge of nose, toe, or bridge of the foot) for the transcutaneous measurement of haemoglobin oxygen saturation (SpO2) in arterial blood using signals produced by a light-emitting diode (LED) and received by a photodetector. The signals are subsequently transmitted to an oximeter/monitor (not included) which measures and displays the SpO2. The is a single-use device.

Regulatory Flags#

DUNS number
031138244
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B21303030Nasal Alar Sp02 Sensor03032017-02-11
B213301112140Nasal Alar Sp02 Sensor301-112142017-03-17
B2130201A012Nasal Alar Sp02 Sensor0201-A012018-03-09
B21303031Nasal Alar Sp02 Sensor03032017-02-11

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Primary DI, Brand, Company table
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