BioPure 4400 RO

FDA UDI

Class II (US FDA UDI)

by Mar Cor Purification, Inc.

Identity

Trade Name: BioPure 4400 RO FDA UDI
Generic Name: Reverse-osmosis water purification system FDA UDI
Model / Reference: 42M16BB2E FDA UDI

Identifiers

Primary DI / UDI-DI: 00817492022164 FDA UDI
FDA Product Code: FIP FDA UDI
GMDN Term: Reverse-osmosis 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

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: Weight — 506 Pound FDA UDI
Height — 80.5 Inch FDA UDI
Depth — 29 Inch FDA UDI
Width — 38 Inch FDA UDI

Category: Reverse-osmosis water purification system

BioPure 4400 RO by Mar Cor Purification, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Reverse-osmosis water purification system.

2436RO, 12600GPD, 230V, 7MEM — Better Water, Inc. · Class II
AquaA — VIVONIC GmbH · Class II
AmeriWater MediQA 00MSP1-230 — AMERIWATER LLC. · Class II
BioPure HX2 — Biolab Equipment Ltd · Class II
3046RO, 19800GPD, 460V, 11MEM — Better Water, Inc. · Class II
AquaB LITE — VIVONIC GmbH · Class II
AquaDETECTOR — VIVONIC GmbH · Class II
Medical Reverse Osmosis — SPECIALITY WATER TECHNOLOGY · Class II

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

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

Manufacturer

Manufacturer: Mar Cor Purification, Inc.

Sources (1)

FDA UDI b7aad23b-9964-486f-becb-1f2248573f05 35 fields · synced Jun 8, 2026