FDA.reportPublic FDA data

Nasal Alar Sp02 Sensor

Primary DI
B213301112140
Brand
Nasal Alar Sp02 Sensor
Company
XHALE ASSURANCE, INC.
Model
301-11214
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 is for use with compatible pulse oximeters. These include: Nellcor OxiMax and Oxisensor II compatible monitors and Philips FAST compatible monitors.
Published
2017-03-17
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
B213301112141PackageHIBCC24In Commercial Distribution
B213301112142PackageHIBCC6In Commercial Distribution
B213301112140PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Pulse oximeter probe, single-useA photoelectric device applied externally to a body site, e.g., a fingertip, ear lobe, the bridge of nose, a toe, or the bridge of the foot of a paediatric or adult patient for the transcutaneous measurement of haemoglobin oxygen saturation (SpO2) in arterial blood using light detection. The signals, typically produced by light-emitting diodes (LEDs) and a receiving detector, are received by an oximeter to which this device is connected. The oximeter displays the SpO2 values and may calculate/display other parameters, e.g., electrocardiogram (ECG). The is a single-use device.

Sterilization Methods#

Method table
Method

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
B2130201A010Nasal Alar Sp02 Sensor0201-A012018-03-09
B21303030Nasal Alar Sp02 Sensor03032017-02-11
B2130201A012Nasal Alar Sp02 Sensor0201-A012018-03-09
B21303031Nasal Alar Sp02 Sensor03032017-02-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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06972040113856N/AShenzhen AOJ Medical Technology Co., LtdDQA2026-07-11
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