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TabloCart™ with Prefiltration Drawer

FDA UDI

Class II (US FDA UDI)

by Outset Medical, Inc.

Identity

Trade Name
TabloCart™ with Prefiltration Drawer FDA UDI
Generic Name
Combination water purification system FDA UDI
Device Name
Prefiltration Drawer, an optional medical device accessory to the Tablo® Hemodialysis System FDA UDI
Model / Reference
PN-0006813 FDA UDI
Description
Prefiltration Drawer, an optional medical device accessory to the Tablo® Hemodialysis System FDA UDI

Identifiers

Primary DI / UDI-DI
00850001011303 FDA UDI
510(k) Number
K232776 FDA UDI
FDA Product Code
FIP FDA UDI
KDI FDA UDI
GMDN Term
Combination water purification system 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

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Combination water purification system

TabloCart™ with Prefiltration Drawer by Outset Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Combination water purification system.

Cleared under the same submission

K232776 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Outset Medical, Inc.

Sources (1)

  • FDA UDI 4233529e-f43b-4ebe-b386-644565e9dc09 34 fields · synced May 30, 2026