Guide
5 Pages
Preview
Page 1
Overview of Ambu’s Medical Devices in relation to content of Latex and REACH Regulated SVHC substances.
PUB-001166 – Updated April 2022
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According to the European Chemical regulation (REACH) Ambu is obligated to inform about products containing listed SVHC substances (Substances of Very High Concern) in concentrations above 0.1% (w/w). See the following website for the current version of the SVHC list: http://echa.europa.eu/web/guest/candidate-list-table The table below provides an overview of all Ambu Medical Devices in relation to content of REACH Regulated SVHC substances in concentrations above 0.1% (w/w). The table also includes information on which products are made with Natural Rubber Latex. All products that has “No” in the SVHC column (column 2) does not contain any substances currently on the SVHC list. Product
Contents of SVHC above 0.1% (w/w) and description of substance
Natural Rubber Latex
Ambu® BlueSensor Electrodes
No
No
Ambu® WhiteSensor Electrodes
No
No
Ambu® Neuroline Electrodes
No
No
Ambu® Neuroline needles (Inoject, concentric, monopolar, subdermal, subdermal twisted)
No
No
Ambu® Neuroline Ground
No
No
Ambu® SkinFix
No
No
No
No
No
No
Ambu® Neuroline Probes
No
No
Ambu® Neuroline Cup electrodes
No
No
Ambu® Snap Clip
No
No
Ambu® Skin Prep
No
No
Ambu® Myoguide
No
No
Ambu® aScope™ 3
No
No
Ambu® aScope™ 4 Broncho
No
No
Ambu® aScope™ 4 RhinoLaryngo
No
No
Ambu® aScope 4 Cysto
No
No
Ambu® aScope™ Duodeno
No
No
Ambu® aScope™ Gastro
No
No
Ambu® aScope BronchoSampler™
No
No
Ambu® aScope BronchoSampler™ SC
No
No
Yes, Lithium battery contains 1,3propanesultone (CASRN 1120-71-4) Yes, Lithium battery contains 1,2dimethoxyethane; ethylene glycol dimethyl ether (EGDME) (CASRN 110-71-4)
No
No
No
Ambu® Neuroline Corkscrew Electrode Ambu® Neuroline Monopolar and Concentric Cables
Ambu® aView™ Ambu® aView™ 2 Advance Ambu® aBox Duodeno
PUB-001166 – Updated April 2022
No
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Product
Contents of SVHC above 0.1% (w/w) and description of substance
Natural Rubber Latex
Ambu® aBox™ 2
No
No
King Vision Video Laryngoscope
No
No
King Vision aBlade video laryngoscope
No
No
King Vision Video Out Cable
No
No
VivaSight-DL
No
No
Ambu® VivaSight™ 2 DLT
No
No
Ambu® VivaSight™ 2 DLT Kit
No
No
VivaSight-SL
No
No
VivaSight-EB
No
No
Ambu® VivaSight™ 2 Endobronchial Blocker Tube
Yes, contains D4 (CASRN 556-67-2), D5 (CASRN 541-02-6) and D6 (CASRN 540976)
No
King Dual Limb Breathing Circuits
No
No
King F2
No
No
King Flex2
No
No
King F Flex2
No
No
King Universal F
No
No
King Universal F Flex
No
No
King Universal F Flex2
No
No
No
No
No
No
King Transport and PACU Kits
No
No
King Breathing Bags (STD and colored)
No
No
HMEs and Filters
No
No
Xenon
No
No
Sampling Line
No
No
King LTS-D
No
No
Nitric Oxide
No
No
Vent Circuits
No
No
Extension Sets
No
No
Flex Connectors
No
No
Headstraps
No
No
King Ped F2 and King Flex 2 Pediatric Breathing Circuits King Jackson Rees and King Mapleson
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Product
Contents of SVHC above 0.1% (w/w) and description of substance
Natural Rubber Latex
Tube Tree
No
No
Manifolds
No
No
Ambu® Disposable Face mask
No
No
Ambu® Open Cuff Silicone Mask
No
No
Ambu® Silicone Face Mask
No
No
Ambu® Transparent Face Mask
No
Yes
Ambu® UltraSeal
No
No
Ambu® King Mask
No
No
Ambu® AuraOnce™
No
No
Ambu® AuraFlex™
No
No
Ambu® AuraStraight™
No
No
Ambu® Aura-i™
No
No
Ambu® Aura40™
No
No
Ambu® AuraGain
No
No
Ambu® Cuff Pressure Gauge
No
No
Ambu® SPUR II
No
No
Ambu® Mark IV
No
No
Ambu® Mark IV Baby
No
No
Ambu® Military Mark III
No
No
Ambu® Oval Silicone resuscitator
No
No
Ambu® Oval Plus Silicone resuscitator
No
No
Ambu® PEEP Valves
No
No
Ambu® Disposable Pressure Manometer
No
No
Ambu® ET Tube holder
No
No
Ambu® LifeKey
No
Yes*
Ambu® ResKey
No
Yes*
Ambu® Res-Cue Mask
No
No
Ambu® Twin Pump
No
No
Ambu® Perfit ACE
No
No
Ambu® Mini Perfit ACE
No
No
Ambu® Perfit
No
No
Ambu® Redi-ACE Adult
No
No
PUB-001166 – Updated April 2022
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Product
Contents of SVHC above 0.1% (w/w) and description of substance
Natural Rubber Latex
Ambu® Redi-ACE Mini
No
No
Ambu® Head Wedge
No
No
*No patient contact with the part containing natural rubber latex
PUB-001166 – Updated April 2022
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