FDA.report

Jaeger

Primary DI
14250892902187
Brand
Jaeger
Company
Vyaire Medical GmbH
Model
705417
Catalog number
705417
Device description
Flexible tube w. elbow and extension
Published
2018-07-13
Public version status
Update
Distribution status
Not 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
14250892902187PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1425089290218714250892902187

GMDN Terms

TermDefinition
Whole-body plethysmographA graphic recorder designed for determining and registering airway resistance and thoracic gas volume to assess pulmonary function. It includes an airtight body chamber and transducers that allow the recording of chamber pressure versus airflow, and chamber pressure versus mouth pressure, to determine the airway resistance. Thoracic gas volume is typically determined by recording the chamber and airway pressures simultaneously with the airway open and with the airway occluded. It may also be possible to determine the instantaneous flow by recording the pulmonary capillary blood flow with the device.

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@vyaire.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
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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14250892906567Vyaire36-TDX105136-TDX10512021-11-15
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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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