FDA.report

Jaeger

Primary DI
04250892900872
Brand
Jaeger
Company
Vyaire Medical GmbH
Model
375111
Catalog number
375111
Device description
APS Pro SA
Published
2016-10-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
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
04250892900872PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04250892900872042508929008724250892900872

GMDN Terms

TermDefinition
Nebulizing system, non-heatedAn assembly of devices designed to generate non-heated aerosolized medication/fluids (finely dispersed airborne droplets in a liquid-phase) intended to be inhaled by a patient with a respiratory disorder [e.g., chronic obstructive pulmonary disease (COPD), cystic fibrosis (CF)]. It includes an electrically-powered generator, a reservoir, and a hand-held nebulizing chamber where the nebulization of the medicine usually takes place.

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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14250892906840Vyaire36-NPROBE0236-NPROBE022025-01-07
14250892906857Vyaire36-NPROBE0336-NPROBE032025-01-07
14250892906864Vyaire36-NPROBE0436-NPROBE042025-01-07
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04250892905228MasterScreenV-175428V-1754282021-04-09
14250892906543Vyaire36-MLD162136-MLD16212021-11-16
14250892906550Vyaire36-TDX104336-TDX10432021-11-16
04250892906645Vyaire7203207203202021-11-15
14250892906499Vyaire7072387072382021-11-15
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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