BodyBox BB-00-01

GUDID 05407003160017

Body plethysmograph with DLCO He Dilution. Inspiratory bag. Standard Size. Pulmonary function testing, measuring lung volumes and airway resistance by

Medi Soft SA

Pulmonary function analysis system, adult
Primary Device ID05407003160017
NIH Device Record Keya9214900-2021-4064-84e1-e7f31c447ff1
Commercial Distribution StatusIn Commercial Distribution
Brand NameBodyBox
Version Model NumberDLCO He IB Si Std
Catalog NumberBB-00-01
Company DUNS393789540
Company NameMedi Soft SA
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Dimensions

Device Size Text, specify0

Operating and Storage Conditions

Handling Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 800 millibar and 1200 millibar
Storage Environment TemperatureBetween -45 Degrees Celsius and 35 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 800 millibar and 1200 millibar

Device Identifiers

Device Issuing AgencyDevice ID
GS105407003160017 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JEHPlethysmograph, Volume

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-15

On-Brand Devices [BodyBox]

05407003160031Body plethysmograph with DLCO He Dilution. Inspiratory bag. WheelChair Size. Pulmonary function
05407003160024Body plethysmograph with DLCO He Dilution. Inspiratory bag. XL Size. Pulmonary function testing,
05407003160017Body plethysmograph with DLCO He Dilution. Inspiratory bag. Standard Size. Pulmonary function te

Trademark Results [BodyBox]

Mark Image

Registration | Serial
Company
Trademark
Application Date
BODYBOX
BODYBOX
87000284 not registered Dead/Abandoned
Shimon, Zachary
2016-04-14
BODYBOX
BODYBOX
78758845 3428350 Dead/Cancelled
F.C. Products Corporation
2005-11-21

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