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AmeriWater 0077-0010 Ozone Disinfection System

FDA UDI

Class II (US FDA UDI)

by Ameriwater Llc.

Identity

Trade Name
AmeriWater 0077-0010 Ozone Disinfection System FDA UDI
Generic Name
Ozone generator, portable FDA UDI
Device Name
Portable Ozone Disinfection System for water storage tanks and bicarb systems. FDA UDI
Model / Reference
0077-0010 FDA UDI
Description
Portable Ozone Disinfection System for water storage tanks and bicarb systems. FDA UDI

Identifiers

Primary DI / UDI-DI
00817927020086 FDA UDI
510(k) Number
K141213 FDA UDI
FDA Product Code
FIN FDA UDI
GMDN Term
Ozone generator, portable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.5820 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
Weight — 70 Pound FDA UDI
Depth — 24 Inch FDA UDI
Width — 15 Inch FDA UDI
Height — 35 Inch FDA UDI

Category: Ozone generator, portable

AmeriWater 0077-0010 Ozone Disinfection System by Ameriwater Llc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Ameriwater Llc.

Sources (1)

  • FDA UDI ae0df625-c029-47fd-baa3-a1ee61938abd 35 fields · synced Jun 8, 2026