FDA.reportPublic FDA data

SleepmateDC Low Impedance Kit

Primary DI
05707480042500
Brand
SleepmateDC Low Impedance Kit
Company
Ambu A/S
Model
815710-100
Catalog number
815710-100
Device description
Ref. 1525
Published
2019-01-03
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LXJSystem, optical position/movement recording

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXJInteractive Rehabilitation Exercise DevicesPhysical Medicine2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K923033000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K923033000THE TRACKEREpm Information Systems, Inc.1993-06-01LXJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05707480042500PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05707480042500057074800425005707480042500

GMDN Terms#

Term, Definition table
TermDefinition
PolysomnographA mains electricity (AC-powered) device designed to record physiological signals from a sleeping patient to assess sleep disorders (e.g., insomnia, snoring or sleep apnoea). The device is typically computerized and usually records an electrocardiogram (ECG), electroencephalogram (EEG), chest wall motion, airflow at both the nose and the mouth, eye movements, haemoglobin oxygen saturation (SpO2) and electromyogram (EMG). Parameters may be added or omitted depending on the study being performed. The device includes multiple electrodes/sensors placed on the patient in specific areas as well as amplifiers and filters for recording.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+14107686464Purchase_orders@ambuUSA.com
+1(410)768-6464Purchase_orders@ambuUSA.com

Regulatory Flags#

DUNS number
305682023
Device count
1
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05707480024650Ambu® Mini Perfit ACE™0002811060002811062022-12-08
05707480024674Ambu® Immobilization Kit, with0002811610002811612022-12-08
05707480026197BlueSensor NEOXECG ElectrodesNEOX-60-K/US/3NEOX-60-K/US/32016-09-21
05707480024513Ambu® Perfit Collar™0002642010002642012022-12-08
05707480024520Ambu® Perfit Collar™0002642020002642022022-12-08
05707480024537Ambu® Perfit Collar™0002642030002642032022-12-08
05707480024544Ambu® Perfit Collar™0002642040002642042022-12-08
05707480024551Ambu® Perfit Collar™0002642050002642052022-12-08
05707480024568Ambu® Perfit Collar™0002642060002642062022-12-08
05707480024575Ambu® Perfit Collar™0002645010002645012022-12-08
05707480024582Ambu® Perfit Collar™0002645020002645022022-12-08
05707480024599Ambu® Perfit Collar™0002645030002645032022-12-08
05707480024605Ambu® Perfit Collar™0002645040002645042022-12-08
05707480024612Ambu® Perfit Collar™0002645050002645052022-12-08
05707480024629Ambu® Perfit Collar™0002645060002645062023-02-09
05707480024636Ambu® Perfit ACE™0002810000002810002022-12-08
05707480024643Ambu® Military Perfit ACE™000281000MIL000281000MIL2022-12-08
05707480024667Ambu® Immobilization Kit, with0002811510002811512022-12-08
05707480037315Ambu® Immobilization Kit, with0002811520002811522022-12-08
05707480038619Ambu® Immobilization Kit, with0002811530002811532022-12-08

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Primary DI, Brand, Company table
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B179SDXEVO1SMARTBTS SPALXJ2023-09-06
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00885556803868ARIASmith & Nephew, Inc.LXJ2021-04-20
07300009074518Qualisys Clinical SystemQualisys ABLXJ2020-09-02
00860001498400VERAREFLEXION HEALTH, INC.LXJ2019-06-30
05707480042548Sleepmate / SparepartBody Position BandAmbu A/SLXJ2019-01-10
05707480042661Body Position Sensor - Alice 3Ambu A/SLXJ2019-01-07
05707480042777VIASYS QDC CABLE GREENAmbu A/SLXJ2019-01-07
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05707480042272SleepmateAC Body Position Sensor KitAmbu A/SLXJ2019-01-03
05707480042555SleepmateAC Body Position SensorAmbu A/SLXJ2019-01-03
05707480042609SleepmateDC Body Position Sensor - ViasysAmbu A/SLXJ2019-01-03
05707480042685SleepmateDC Body Position Sensor - CadwellAmbu A/SLXJ2019-01-03
05707480042715SleepmateBody Position Sensor - Alice 5Ambu A/SLXJ2019-01-03
05707480042838SleepmateBody Position - CadwellAmbu A/SLXJ2019-01-03
05707480043477SleepmateBody Position SensorAmbu A/SLXJ2019-01-03
03760272650019MindMotion™ GONeuroXtherapeutics SALXJ2018-05-28
03760272650002MindMotion PRONeuroXtherapeutics SALXJ2017-08-01
00863090000400SaeboVRVIRTUAL THERAPY SOLUTIONS, LLC.LXJ2017-06-01
B548BONITASYSTEM0VICONVICON MOTION SYSTEMS LIMITEDLXJ2017-04-18
B548VICONTSERIESSYSTEM0VICONVICON MOTION SYSTEMS LIMITEDLXJ2017-04-18
B548VICONVANTAGESYSTEM0VICONVICON MOTION SYSTEMS LIMITEDLXJ2017-04-18
B548VICONVEROSYSTEM0VICONVICON MOTION SYSTEMS LIMITEDLXJ2017-04-18
B179SDXSMARTBTS SPALXJ2017-02-12