ri-integral set Macintosh XL 2.5 V, with C-handle,

FDA UDI

Class I (US FDA UDI)

by Rudolf Riester GmbH & Co. KG

Identity

Trade Name: ri-integral set Macintosh XL 2.5 V, with C-handle, FDA UDI
Generic Name: Rigid intubation laryngoscope, reusable FDA UDI
Device Name: The laryngoscopes are manufactured in order to be used for endotracheal intubation. The Riester battery handles are used in order to supply the bulbs with energy and for fixation of the blades. FDA UDI
Model / Reference: 8040 FDA UDI
Description: The laryngoscopes are manufactured in order to be used for endotracheal intubation. The Riester battery handles are used in order to supply the bulbs with energy and for fixation of the blades. FDA UDI

Identifiers

Catalog Number: 8040 FDA UDI
Primary DI / UDI-DI: 04045396008274 FDA UDI
510(k) Number: K945425 FDA UDI
FDA Product Code: CCW FDA UDI
GMDN Term: Rigid intubation laryngoscope, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 868.5540 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

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Rigid intubation laryngoscope, reusable

ri-integral set Macintosh XL 2.5 V, with C-handle, by Rudolf Riester GmbH & Co. KG — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K945425 also covers:

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: Rudolf Riester GmbH & Co. KG

Sources (1)

FDA UDI 1698dca8-4720-4268-b10f-2ace5743b9fe 35 fields · synced May 29, 2026