FDA.reportPublic FDA data

Perfect Fit

Primary DI
00817377020469
Brand
Perfect Fit
Company
DYMEDIX DIAGNOSTICS, INC.
Model
11-42403-0601
Device description
Perfect Fit ™II Adult Effort Belt Sensor, Abdomen, Alice 5
Published
2016-10-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
BZQMonitor, Breathing Frequency

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BZQMonitor, Breathing FrequencyAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K040605000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K040605000DYMEDIX REUSABLE RESPIRATORY EFFORT BELT SENSOR, MODEL 6015 AND DYMEDIX REUSABLE LIMB MOVEMENT SENSOR, MODEL 3100Dymedix, Inc.2004-04-26BZQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817377020469PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817377020469008173770204698173770204690817377020469

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

Regulatory Flags#

DUNS number
079976463
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817377022791SnuggleFit11-15000-00102021-07-21
00817377023002Perfect Fit11-44100-75012021-07-21
00817377023019Perfect Fit11-44200-75012021-07-21
00817377023026Perfect Fit11-44300-75022021-07-21
00817377021855Perfect Fit11-42307-06012021-07-21
00817377021862Perfect Fit11-42407-06012021-07-21
00817377022494Perfect Fit11-14001-10012021-07-21
00817377022500SnuggleFit11-14002-10012021-07-21
00817377022517SnuggleFit11-14002-50012021-07-21
00817377022531SnuggleFit18-13300-00012021-07-21
00817377022548SnuggleFit18-13301-00012021-07-21
00817377022555SnuggleFit18-13302-00012021-07-21
00817377022562SnuggleFit18-13304-00012021-07-21
00817377022579SnuggleFit18-13305-00012021-07-21
00817377022586SnuggleFit18-13310-00012021-07-21
00817377022807SnuggleFit11-15000-00102021-07-21
00817377022944Perfect Fit11-42710-06012021-07-21
00817377022951Perfect Fit11-42810-06012021-07-21
00817377022975Perfect Fit11-94320-06012021-07-21
00817377022982Perfect Fit11-94321-06012021-07-21

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