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AmeriWater Heatsan 00HS460

FDA UDI

Class II (US FDA UDI)

by Ameriwater Llc.

Identity

Trade Name
AmeriWater Heatsan 00HS460 FDA UDI
Generic Name
Haemodialysis water purification system washer-disinfector (thermal) FDA UDI
Device Name
Heatsan, 460V, 3 Phase, Heat Disinfection System for Distribution Loops FDA UDI
Model / Reference
00HS460 FDA UDI
Description
Heatsan, 460V, 3 Phase, Heat Disinfection System for Distribution Loops FDA UDI

Identifiers

Primary DI / UDI-DI
00817927020031 FDA UDI
510(k) Number
K142285 FDA UDI
FDA Product Code
FIP FDA UDI
GMDN Term
Haemodialysis water purification system washer-disinfector (thermal) FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.5665 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

No

FDA UDI

Over-the-Counter

Yes

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

No

FDA UDI

Dimensions & Sizes

Size
Width — 28 Inch FDA UDI
Depth — 35 Inch FDA UDI
Height — 70 Inch FDA UDI
Weight — 1580 Pound FDA UDI

Category: Haemodialysis water purification system washer-disinfector (thermal)

AmeriWater Heatsan 00HS460 by Ameriwater Llc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Haemodialysis water purification system washer-disinfector (thermal).

Cleared under the same submission

K142285 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Ameriwater Llc.

Sources (1)

  • FDA UDI cd67bc3d-8b52-4e71-af9e-d404615d75b1 35 fields · synced May 30, 2026