Ak 98

FDA UDI

Class II (US FDA UDI)

by Gambro, Inc.

Identity

Trade Name: AK 98 FDA UDI
Generic Name: Haemodialysis system, institutional/home-use FDA UDI
Device Name: Intended for intermittant haemodialysis and/or isolated ultrafiltration treatments. Indicated to be used on patients with a body weight of 25 kg or more. To be used by trained operators in chronic care dialysis or hospital care environment. Not intended for Self-care or Home use. FDA UDI
Model / Reference: 955607 FDA UDI
Description: Intended for intermittant haemodialysis and/or isolated ultrafiltration treatments. Indicated to be used on patients with a body weight of 25 kg or more. To be used by trained operators in chronic care dialysis or hospital care environment. Not intended for Self-care or Home use. FDA UDI

Identifiers

Catalog Number: 955607 FDA UDI
Primary DI / UDI-DI: 07332414124519 FDA UDI
510(k) Number: K201809 FDA UDI
K232467 FDA UDI
K250508 FDA UDI
FDA Product Code: KDI FDA UDI
GMDN Term: Haemodialysis system, institutional/home-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 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

Dimensions & Sizes

Size: Width — 585 Millimeter FDA UDI
Depth — 620 Millimeter FDA UDI
Height — 1305 Millimeter FDA UDI

Category: Haemodialysis system, institutional/home-use

Ak 98 by Gambro, 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

K201809 also covers:

BLOOD CIRCUIT SET — Baxter Healthcare Corp

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: Gambro, Inc.

Sources (1)

FDA UDI fc37e6f8-721e-4b36-93f1-37ab7a4dde31 38 fields · synced May 31, 2026