Millennium

FDA UDI

Class I (US FDA UDI)

by AVALIGN TECHNOLOGIES, Inc.

Identity

Trade Name: Millennium FDA UDI
Generic Name: Peritoneal dialysis system FDA UDI
Device Name: HEGAR DILATOR DOUBLE END 12" 13mm/14mm FDA UDI
Model / Reference: 1-7021314-12 FDA UDI
Description: HEGAR DILATOR DOUBLE END 12" 13mm/14mm FDA UDI

Identifiers

Primary DI / UDI-DI: 00190776406684 FDA UDI
FDA Product Code: HDQ FDA UDI
GMDN Term: Peritoneal dialysis system FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 884.4530 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

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Peritoneal dialysis system

Millennium by AVALIGN TECHNOLOGIES, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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 I	Pending data

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Manufacturer

Manufacturer: AVALIGN TECHNOLOGIES, Inc.

Sources (1)

FDA UDI e7523534-3eb8-4368-a447-6f19226d2268 34 fields · synced Jun 8, 2026