FDA.reportPublic FDA data

F.O. Laryngoscope Set 2.5 V for Neonatal

Primary DI
04030155019332
Brand
F.O. Laryngoscope Set 2.5 V for Neonatal
Company
Kirchner & Wilhelm GmbH + Co KG
Model
03.62125.011
Catalog number
03.62125.011
Published
2023-09-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
CCWLaryngoscope, Rigid

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CCWLaryngoscope, RigidAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04030155019332PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04030155019332040301550193324030155019332

GMDN Terms#

Term, Definition table
TermDefinition
Laryngoscope blade, reusableThe segment of a laryngoscope (i.e., rigid intubation type) intended to be inserted into the oral cavity to manipulate the tongue, preventing it from obstructing the oropharynx and enabling a clear view of the trachea for the insertion of an endotracheal (ET) tube prior to the delivery of inhalation anaesthesia and/or ventilation. It is connected to the laryngoscope handle and illumination of the airway is provided by a small built-in light bulb or a fibreoptic light. This device may be curved or straight and of various designs and lengths; it may be hinged/interchanged with the handle. Some types are magnetic resonance imaging (MRI) compatible. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
315480269
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04030155000644Ear funnel, grey, small, Ø 2,5 mm, PU = 1000 pcs.01.71211.00201.71211.0022026-06-25
04030155000675Ear funnel, grey, large, Ø 4,0 mm, PU = 1000 pcs.01.71221.00201.71221.0022026-06-25
04030155008480MedCharge 4000 battery charger compl. with mains adaptor12.80005.00212.80005.0022025-10-27
04030155004819Colorscop-duo stethoscope, pink06.22100.13406.22100.1342023-09-12
04030155004970Standard-Prestige stethoscope stainless steel, black06.22700.02206.22700.0222023-09-12
04030155005076Planet double stethoscope according to Fassbender06.22900.02206.22900.0222023-09-12
04030155005168Ear tips, black, Ø 5,5 mm, PU: 10 pcs. W. white turned parts06.91111.02106.91111.0212023-09-12
04030155011695Stethoscope double tube, black, length 60cm06.93265.02106.93265.0212023-09-12
04030155019448Planet Air stethoscope06.22910.12206.22910.1222023-09-12
04030155004987Standard-Prestige stethoscope stainless steel, blue06.22700.03206.22700.0322024-01-11
04030155004994Standard-Prestige stethoscope stainless steel, burgundy06.22700.17206.22700.1722024-01-11
04030155005007Baby-Prestige stethoscope stainless steel, black06.22701.02206.22701.0222024-01-11
04030155005038Children-Prestige stethoscope stainless steel, blue06.22702.03206.22702.0322024-01-11
04030155018960Children-Prestige stethoscope stainless steel, black06.22702.02206.22702.0222024-01-11
04030155019011Baby-Prestige stethoscope stainless steel, blue06.22701.03206.22701.0322024-01-11
04030155000774Reusable ear funnels Ø 4.0 mm, 10 pcs.01.72213.0012024-07-24
04030155000392EUROLIGHT E30, 2.5V ophthalmoscope with clic-closure01.21300.00101.21300.0012023-09-04
04030155001542BASIC-SET COMBILIGHT C10/E10 ophthalmoscope and otoscope02.11001.00202.11001.0022023-09-04
04030155010346PICCOLIGHT C otoscope, sky with ear funnels, cloth bag01.13100.23201.13100.2322023-09-04
04030155010353PICCOLIGHT C otoscope, stone with ear funnels, cloth bag01.13100.26201.13100.2622023-09-04

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