FDA.reportPublic FDA data

SleepmateBody Position - Cadwell

Primary DI
05707480042838
Brand
SleepmateBody Position - Cadwell
Company
Ambu A/S
Model
815030-000
Catalog number
815030-000
Device description
Ref. 1542
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
05707480042838PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05707480042838057074800428385707480042838

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
05707480024438Head Wedge™0002640340002640342022-12-08
05707480024476Head Wedge™0002640360002640362022-12-08
05707480024490Military Head Wedge™0002640640002640642022-12-08
05707480135363SPUR® II Adult ResuscitatorSingle Patient Use Resuscitator5206111015206111012017-10-13
05707480135585SPUR® II Adult ResuscitatorSingle Patient Use Resuscitator5236310115236310112018-07-09
05707480135615SPUR® II Pediatric ResuscitatorSingle Patient Use Resuscitator5306390115306390112017-10-13
05707480136018SPUR® II Infant ResuscitatorSingle Patient Use Resuscitator5442160475442160472018-05-28
05707480145294SPUR® II Adult Resuscitator5246140005246140002020-06-24
05707480145317SPUR® II Pediatric Resuscitator5316160005316160002020-06-24
05707480145348SPUR® II Adult Resuscitator5206110745206110742020-06-24
05707480145393SPUR® II Adult Resuscitator520211000BE520211000BE2021-04-13
05707480145416SPUR® II Adult Resuscitator520211000E520211000E2021-04-13
05707480145430SPUR® II Adult Resuscitator520211001E520211001E2021-04-13
05707480145454SPUR® II Adult Resuscitator520211010E520211010E2021-04-13
05707480145478SPUR® II Adult Resuscitator520214000E520214000E2021-04-13
05707480145492SPUR® II Adult Resuscitator520611000E520611000E2021-04-13
05707480145515SPUR® II Adult Resuscitator521611000E521611000E2021-04-13
05707480145539SPUR® II Adult Resuscitator523211000E523211000E2021-04-13
05707480145553SPUR® II Adult Resuscitator523211001E523211001E2021-04-13
05707480145577SPUR® II Adult Resuscitator523611030E523611030E2021-04-13

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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B179SEVBUN020SMARTBTS SPALXJ2024-12-20
B179SDXEVO1SMARTBTS SPALXJ2023-09-06
00627843933236KneeKG systemEmovi IncLXJ2022-03-23
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
05707480042807VIASYS QDC CABLE BROWNAmbu A/SLXJ2019-01-07
05707480042272SleepmateAC Body Position Sensor KitAmbu A/SLXJ2019-01-03
05707480042500SleepmateDC Low Impedance 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
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