EverFlo Connect

FDA UDI

Class I (US FDA UDI)

by Respironics, Inc.

Identity

Trade Name: EverFlo Connect FDA UDI
Generic Name: Clinical laboratory information system FDA UDI
Device Name: EverFlo Connect Module, US FDA UDI
Model / Reference: EverFlo Connect Module, US FDA UDI
Description: EverFlo Connect Module, US FDA UDI

Identifiers

Catalog Number: 1128984 FDA UDI
Primary DI / UDI-DI: 00606959044258 FDA UDI
FDA Product Code: OUG FDA UDI
GMDN Term: Clinical laboratory information system FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 880.6310 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

Yes

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Clinical laboratory information system

EverFlo Connect Module, a dedicated clinical laboratory information system designed to streamline administrative and clinical activities within healthcare facilities. This user-friendly system electronically receives, collects, stores, displays, outputs, and distributes clinical laboratory data, supporting the needs of healthcare professionals and facilities. Built with a combination of dedicated hardware and software, EverFlo Connect simplifies data management and analysis, making it an essential tool for medical laboratories.

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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: Respironics, Inc.

Sources (1)

FDA UDI b0ac59c9-ca96-493e-9e74-f78caa2c07d9 36 fields · synced Jun 23, 2026