BodyBox

Primary DI
05407003160017
Brand
BodyBox
Company
Medi Soft SA
Model
DLCO He IB Si Std
Catalog number
BB-00-01
Device description
Body plethysmograph with DLCO He Dilution. Inspiratory bag. Standard Size. Pulmonary function testing, measuring lung volumes and airway resistance by spirometry and body plethysmography.
Published
2016-09-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
JEHPlethysmograph, Volume

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JEHPlethysmograph, VolumeAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K022636000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K022636000BODY BOX 5500Morgan Scientific, Inc.2003-01-13JEH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05407003160017PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05407003160017054070031600175407003160017

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].

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure800 millibar1200 millibar
Handling Environment Humidity15 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius35 Degrees Celsius
Storage Environment Atmospheric Pressure800 millibar1200 millibar
Storage Environment Humidity15 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-45 Degrees Celsius35 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
393789540
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05407003160024BodyBoxDLCO He IB Si XLBB-00-022016-09-15
05407003160031BodyBoxDLCO He IB Si WheelChairBB-00-032016-09-15
05407003162011TransAir3TransAir310-SA-03-TA2016-09-15
05407003163018SpiroAirSpiroAir DLCO-He IBSP-00-022016-09-15

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