ri-integral blade with integrated F.O.

FDA UDI

Class I (US FDA UDI)

by Rudolf Riester GmbH & Co. KG

Identity

Trade Name: ri-integral blade with integrated F.O. FDA UDI
Generic Name: Rigid intubation laryngoscope, reusable FDA UDI
Device Name: The laryngoscopes are manufactured in order to be used for endotracheal intubation. FDA UDI
Model / Reference: 12233 FDA UDI
Description: The laryngoscopes are manufactured in order to be used for endotracheal intubation. FDA UDI

Identifiers

Catalog Number: 12233 FDA UDI
Primary DI / UDI-DI: 04045396021594 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 blade with integrated F.O. by Rudolf Riester GmbH & Co. KG — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Rigid intubation laryngoscope, reusable.

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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 e87dcb19-5609-4372-9f67-3bfc59c65887 35 fields · synced Jun 8, 2026