Tablo(R) Hemodialysis System

FDA UDI

Class II (US FDA UDI)

by Outset Medical, Inc.

Identity

Trade Name: Tablo(R) Hemodialysis System FDA UDI
Generic Name: Haemodialysis system, institutional FDA UDI
Device Name: The Tablo 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. FDA UDI
Model / Reference: PN-0003000 FDA UDI
Description: The Tablo 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. FDA UDI

Identifiers

Catalog Number: PN-0003000 FDA UDI
Primary DI / UDI-DI: 00850001011112 FDA UDI
FDA Product Code: FIP FDA UDI
KDI FDA UDI
GMDN Term: Haemodialysis system, institutional FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 876.5665 FDA UDI
876.5860 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Haemodialysis system, institutional

Tablo(R) Hemodialysis System by Outset Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Molded Products, Inc. — MOLDED PRODUCTS INC. · Class II
Molded Products, Inc. — MOLDED PRODUCTS INC. · Class II
Molded Products, Inc. — MOLDED PRODUCTS INC. · Class II

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Outset Medical, Inc.

Sources (1)

FDA UDI b6064c95-6f58-4067-a71a-60e9c35946a8 36 fields · synced Jun 6, 2026