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: 42M16B2F FDA UDI

Identifiers

Primary DI / UDI-DI: 00817492021938 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

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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

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Manufacturer

Manufacturer: Mar Cor Purification, Inc.

Sources (1)

FDA UDI c47b35b4-c543-4307-9021-ace44f6842f5 35 fields · synced Jun 1, 2026