FDA Device Entity Profile: Outset Medical, Inc.

Known Identifiers & Locations

FEI Numbers 3010355846, 3017552925, 3038138522

Owner Operator Numbers 10047467

Locations Covered San Jose, CA, US; Tijuana BC. Baja California, MX; Tijuana Baja California, MX

Registration #	Establishment Name	Location	Establishment Type(s)	Action
3010355846	Outset Medical, Inc.	San Jose, CA, US	Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility	View Details
3017552925	Baja Fur S.A. de C.V.	Tijuana Baja California, MX	Manufacture Medical Device	View Details
3038138522	Baja Fur S.A. de C.V.	Tijuana BC. Baja California, MX	Develop Specifications But Do Not Manufacture At This Facility	View Details

No 510(k) notifications found for this entity.

Recall #	Product Description	Initiation Date	Status	Action
Z-0019-2025	Tablo Console, REF: PN-0003000, PN-0006000, part of the Tablo Hemodialysis System. The Tablo Hemodialysis System is indicated for use in patients with acute and/or chronic renal failure, with or without ultrafiltration, in an acute or chronic care facility. Reason: Blood leak sensor, a component of hemodialysis device, may show decreased sensitivity, at the lowest level, specified as 0.35 mL/min blood leak rate, which could delay triggering the ALARM_DIALYZER_BLOOD_LEAK alarm, if blood loss, less-than 300ml, occurs, the patient may experience hypotension, fatigue, cramps, dizziness, headaches, nausea, and shortness of breath.	2024-08-01	Open, Classified	View Details

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Outset Medical, Inc.

Known Identifiers & Locations

Registered Establishments (3)

510(k) Premarket Notifications (0)

FDA Recall History (1)

Profile Disclaimer