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US
Last updated May 30, 2026
What XHALE ASSURANCE, INC. makes
XHALE ASSURANCE, INC. manufactures single-use pulse oximeter probes. Specifically, the company produces nasal alar SpO2 sensors designed for patient monitoring.
These devices are classified as Class II medical devices. The company is based in the United States, and its products are listed in the FDA UDI database.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What type of medical devices does Xhale Assurance, Inc. manufacture?
Xhale Assurance, Inc. specializes in the production of single-use pulse oximeter probes. Specifically, the company manufactures nasal alar SpO2 sensors, which are designed for patient monitoring applications. This information is based on the company's product summary, which identifies these sensors as their primary focus.
Where is Xhale Assurance, Inc. based?
Xhale Assurance, Inc. is based in the United States. This location is confirmed by the company profile data provided, which specifies the country of origin for the manufacturer.
How are the devices from Xhale Assurance, Inc. classified and where can I find them listed?
The devices produced by Xhale Assurance, Inc. are classified as Class II medical devices. You can find these products listed in the FDA UDI database. This classification and registry information is provided directly in the company's regulatory data summary.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 031138244
Catalogue (3)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Nasal Alar Sp02 Sensor | 0201-A01 | FDA UDI | Class II | Active |
| Nasal Alar Sp02 Sensor | 0303 | FDA UDI | Class II | Active |
| Nasal Alar Sp02 Sensor | 301-11214 | FDA UDI | Class II | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
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Notified Bodies
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Authorities
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FDA Recalls (1)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
XHALE ASSURANCE, INC. has one recall record initiated on 2019-05-08, which is recorded as terminated. The reason stated in the filing was that the Instructions for Use were missing specific instructions related to the checking and changing of the application site procedure.
AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| May 8, 2019 | Z-2133-2019 | — | terminated | These Instructions for Use has missing instructions related to the checking and changing of the application site procedure. |