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/home-use FDA UDI
Device Name: Tablo Console FDA UDI
Model / Reference: PN-0007001 FDA UDI
Description: Tablo Console FDA UDI

Identifiers

Primary DI / UDI-DI: 00850001011341 FDA UDI
510(k) Number: K200741 FDA UDI
K211370 FDA UDI
K223248 FDA UDI
K233335 FDA UDI
FDA Product Code: KDI FDA UDI
FIP FDA UDI
GMDN Term: Haemodialysis system, institutional/home-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 876.5860 FDA UDI
876.5665 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

MRI Safety

MR Unsafe FDA UDI

Category: Haemodialysis system, institutional/home-use

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

Similar devices

Also classified as Haemodialysis system, institutional/home-use.

NXVIEW TOUCH SCREEN — NxStage Medical, Inc. · Class II
2008® Series Hemodialysis Machines — Fresenius Usa, Inc. · Class II
NXSTAGE SYSTEM ONE PLUS — NxStage Medical, Inc. · Class II
NXView Touch Monitor — NxStage Medical, Inc. · Class II
Moda-flx Hemodialysis System — Diality, Inc. · Class II
NXSTAGE SYSTEM ONE — NxStage Medical, Inc. · Class II
2008® Series Hemodialysis Machines — Fresenius Usa, Inc. · Class II
NXSTAGE SYSTEM ONE — NxStage Medical, Inc. · Class II

Cleared under the same submission

K200741 also covers:

K211370 also covers:

K223248 also covers:

K233335 also covers:

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 a0024bcf-813f-4b02-b03d-3ac246837bef 36 fields · synced Jun 6, 2026