Nasal Alar Sp02 Sensor

GUDID B2130201A012

The Assurance® Nasal Alar SpO2™ Sensor is indicated for single patient use for continuous noninvasive monitoring of functional oxygen saturation of

XHALE ASSURANCE, INC.

Pulse oximeter probe, single-use

• Primary Device ID: B2130201A012
• NIH Device Record Key: c4ca9764-3bf9-4e03-9ccf-0ecbe36a640f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Nasal Alar Sp02 Sensor
• Version Model Number: 0201-A01
• Company DUNS: 031138244
• Company Name: XHALE ASSURANCE, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B2130201A010 [Primary]
HIBCC	B2130201A011 [Package]; Contains: B2130201A010; Package: Case [20 Units]; In Commercial Distribution
HIBCC	B2130201A012 [Package]; Contains: B2130201A011; Package: Shipping Carton [6 Units]; In Commercial Distribution

FDA Product Code

• DQA: Oximeter

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-04-09
• Device Publish Date: 2018-03-09

On-Brand Devices [Nasal Alar Sp02 Sensor]

• B213301112140: The Assurance® Nasal Alar SpO2™ Sensor is indicated for single patient use for continuous no
• B21303031: The Assurance® Nasal Alar SpO2™ Sensor is indicated for single patient use for continuous no
• B2130201A012: The Assurance® Nasal Alar SpO2™ Sensor is indicated for single patient use for continuous no