Pro-Flow

FDA UDI

Class II (US FDA UDI)

by Respironics, Inc.

Identity

Trade Name: Pro-Flow FDA UDI
Generic Name: Polysomnograph FDA UDI
Device Name: PRO-FLOW MULTIPURPOSE NASAL CANNULA, M-F 0.35x 0.35, Single FDA UDI
Model / Reference: PRO-FLOW NASAL CANNULA, M-F 0.35 x 0.35, Single FDA UDI
Description: PRO-FLOW MULTIPURPOSE NASAL CANNULA, M-F 0.35x 0.35, Single FDA UDI

Identifiers

Catalog Number: 1097346 FDA UDI
Primary DI / UDI-DI: 00606959032354 FDA UDI
FDA Product Code: OLV FDA UDI
GMDN Term: Polysomnograph FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 882.1400 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

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Polysomnograph

Pro-Flow by Respironics, Inc. — Class II — 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 II	Pending data

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Manufacturer

Manufacturer: Respironics, Inc.

Sources (1)

FDA UDI 45600775-042e-4478-afd2-135797d4cd4b 35 fields · synced Jun 8, 2026