Shape

Primary DI
B200HF012
Brand
Shape
Company
Shape Medical Systems, Inc.
Model
HF012
Device description
Paramagnetic Shape analyzer Product 0012
Published
2019-05-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
BTYCalculator, Predicted Values, Pulmonary Function

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BTYCalculator, Predicted Values, Pulmonary FunctionAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K150888000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K150888000Shape-HF Cardiopulmonary Testing SystemShape Medical Systems, Inc.2016-01-21BTY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B200HF012PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Pulmonary function analysis system, adultA device used to measure the function of the respiratory system in adults and compliant children. It usually includes a spirometer with volume-sensing (e.g., rolling-seal, bellow) and flow-sensing (e.g., pneumotachometer) devices, a gas analyser for evaluation of absolute lung volumes and gas-diffusing capacity of the lungs, and computer capabilities for data processing and recording; a total-body plethysmograph to measure both lung volumes and airway resistance may be included. The device is mostly used for outpatient or presurgical screening, and may also be used in the diagnosis and evaluation of common diseases in older children [e.g., asthma, cystic fibrosis (CF), chest deformities].

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
021315587
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B2009012Shape II System Refurbished0012-90122022-04-14
B20083012Shape Vital Sign System0008-30122019-05-02
B20044012Disposable Patient Interface with filter0004-40122019-05-02
B20040011ShapeShape2016-09-14
B20044001Shape-HFDisposable Patient Interface2016-09-13
B20089001Shape-HF0008-90012016-10-26
B200HF001Shape-HFHF0012016-09-13

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