← Back to catalogue

Ul Listed Medi-Port Pbii R.o. 120v

FDA UDI

Class II (US FDA UDI)

by Better Water, Inc.

Identity

Trade Name
UL LISTED MEDI-PORT PBII R.O. 120V FDA UDI
Generic Name
Combination water purification system FDA UDI
Device Name
Portable reverse osmosis machine for water purification for dialysis applications. FDA UDI
Model / Reference
EQROPB1613 UL FDA UDI
Description
Portable reverse osmosis machine for water purification for dialysis applications. FDA UDI

Identifiers

Catalog Number
EQROPB1613 UL FDA UDI
Primary DI / UDI-DI
PB0001 FDA UDI
510(k) Number
K954928 FDA UDI
FDA Product Code
FIP FDA UDI
GMDN Term
Combination water purification system 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

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

No

FDA UDI

Category: Combination water purification system

Ul Listed Medi-Port Pbii R.o. 120v by Better Water, 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

K954928 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Better Water, Inc.

Sources (1)

  • FDA UDI d5be1337-0e7b-4c37-b13a-e22fdabafb18 35 fields · synced Jun 8, 2026