One-AI Healthcare, Inc

FDA Device Registration & Listing · Redmond, WA, US · Registration 3015216264

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3015216264
FEI Number
3015216264
Entity Name
One-AI Healthcare, Inc
City/State/Country
Redmond, WA, US
Establishment Address
14860 Ne 95th St, Redmond, WA 98052, US
Establishment Type(s)
Repack or Relabel Medical Device
Owner / Operator
PatCen Healthcare, Inc (Owner Number: 10059549)
Owner / Operator Contact Address
3600 136th Pl SE #300, Bellevue, WA 98006, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

1Scope OneScope Pro OneScope Pro, OneStylet

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
CCW Laryngoscope, Rigid Anesthesiology Class 1 868.5540 2019-01-31
BSR Stylet, Tracheal Tube Anesthesiology Class 1 868.5790 2024-12-03

Official Correspondent

Sujit Kumar

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

PatCen Healthcare, Inc
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0144-2024 Covidien 1
Stolen McGRATH MAC Video Laryngoscopes, REF: 301-000-000
Z-0168-2024 Covidien 1
McGrath Mac 2, Disposable Laryngoscope Blade, REF: 350-017-000, Sterile EO, Rx Only
Z-0169-2024 Covidien 1
McGrath Mac 2, Disposable Laryngoscope Blade, REF: 350-084-000, Sterile EO, Rx Only

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015216264. Last updated year: 2026. Please use registration number 3015216264 when referencing this establishment in official correspondence.
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