FDA.report

Jaeger

Primary DI
04250892900513
Brand
Jaeger
Company
Vyaire Medical GmbH
Model
V-176420-13
Catalog number
V-176420-13
Device description
MasterScreen IOS
Published
2016-08-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
BZCCalculator, Pulmonary Function Data

Product Code Classifications

CodeDeviceSpecialtyClass
BZCCalculator, Pulmonary Function DataAnesthesiology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04250892900513PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04250892900513042508929005134250892900513

GMDN Terms

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].

Storage And Handling

TypeLowHighCondition
Storage Environment Humidity15 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius50 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
+499314972127support.rt.eu.jae@carefusion.c
+499314972127support.rt.eu.jae@carefusion.com

Regulatory Flags

DUNS number
329769991
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

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14250892906833Vyaire36-NPROBE0136-NPROBE012025-01-07
14250892906840Vyaire36-NPROBE0236-NPROBE022025-01-07
14250892906857Vyaire36-NPROBE0336-NPROBE032025-01-07
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14250892906550Vyaire36-TDX104336-TDX10432021-11-16
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14250892906529Vyaire7072257072252021-11-15
14250892906536Vyaire7072307072302021-11-15
14250892906567Vyaire36-TDX105136-TDX10512021-11-15
14250892906574Vyaire36-TDX104836-TDX10482021-11-15
14250892906635Vyaire36-TDX105036-TDX10502021-11-15
14250892906659Vyaire7110077110072021-11-15
14250892906680Vyaire36-MFA105036-MFA10502021-09-24
14250892906697Vyaire36-MFA101036-MFA10102021-09-24
14250892906703Vyaire36-ASS127036-ASS12702021-09-24

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