FDA.reportPublic FDA data

Vyaire

Primary DI
14250892906178
Brand
Vyaire
Company
Jaeger Medical GmbH
Model
852760
Catalog number
852760
Device description
"""Squeeze Jacket, size XXS, colour yellow"""
Published
2021-06-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
CCMPlethysmograph, Pressure

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CCMPlethysmograph, PressureAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K081823000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K081823000MASTERSCREEN PAED - BABY BODYViasys Healthcare GmbH2009-05-18CCM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14250892906178PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1425089290617814250892906178

GMDN Terms#

Term, Definition table
TermDefinition
Pulmonary function analysis system, paediatricA computerized instrument designed to assess lung volume, flow, and mechanical parameters (including airway compliance and resistance) in young children and infants. It is different from an adult version in absolute dimensions and in the special procedures required for adaption to the pediatric patient (e.g., use of a small constant-volume chamber in which the infant reclines for plethysmography, use of a pressure jacket to obtain forced exhalation); also, parameters that require subject cooperation (e.g., vital capacity, forced expiratory volume) can't be determined. The device is used for pulmonary function testing in diagnostic studies and for evaluation of diseases and chest deformities.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity15 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius50 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+499314972127support.rt.eu.jae@vyaire.com

Regulatory Flags#

DUNS number
329769991
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04250892907352SentrySuite Software3.20V-7709652025-11-24
04250892908700Jaeger375119-13375119-132025-11-24
04250892908717Jaeger7066967066962025-11-24
04250892908731JaegerV-176420-13V-176420-132025-11-24
04250892908816Jaeger705560N705560N2025-11-24
04250892908823JaegerV-707525V-7075252025-11-24
04250892908861JaegerV-171470-13V-171470-132025-11-24
04250892908984JaegerV-577400-13V-577400-132025-11-24
04250892908991JaegerV-577084-13V-577084-132025-11-24
04250892909004Jaeger5.7V-770868-132025-11-24
04250892909059Jaeger28-835809-0012025-11-24
04250892909066Jaeger28-4b23795-0012025-11-24
14250892907243Jaeger36-NPROBETU2025-11-24
14250892907250Jaeger36-NPROBE0136-NPROBE012025-11-24
14250892907267Jaeger36-NPROBE0236-NPROBE022025-11-24
14250892907274Jaeger36-NPROBE0336-NPROBE032025-11-24
14250892907281Jaeger36-NPROBE0436-NPROBE042025-11-24
14250892908509Jaeger36-TDX105036-TDX10502025-11-24
14250892908905JaegerV-707183V-7071832025-11-24
14250892908929Jaeger36-PSA180036-PSA18002025-11-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04250892908823JaegerJaeger Medical GmbHCCM2025-11-24
14250892908905JaegerJaeger Medical GmbHCCM2025-11-24
14250892907045JaegerJaeger Medical GmbHCCM2025-08-14
14250892907052JaegerJaeger Medical GmbHCCM2025-08-14
14250892907069JaegerJaeger Medical GmbHCCM2025-08-14
14250892907519JaegerJaeger Medical GmbHCCM2025-07-23
14250892906260VyaireJaeger Medical GmbHCCM2023-01-03
14250892906185VyaireJaeger Medical GmbHCCM2021-07-16
14250892906192VyaireJaeger Medical GmbHCCM2021-07-16
14250892906239VyaireJaeger Medical GmbHCCM2021-07-16
14250892906161VyaireJaeger Medical GmbHCCM2021-06-10
00852417003514KoKo, LLCKoko, LLCCCM2021-04-16
14250892903696VyaireJaeger Medical GmbHCCM2019-06-04
04250892905006JaegerJaeger Medical GmbHCCM2019-03-20
14250892903337VyaireJaeger Medical GmbHCCM2019-03-19
14250892903344VyaireJaeger Medical GmbHCCM2019-03-19
14250892903351VyaireJaeger Medical GmbHCCM2019-03-19
14250892904259VyaireJaeger Medical GmbHCCM2019-03-19
14250892904518VyaireJaeger Medical GmbHCCM2019-03-19
04250892904993JaegerJaeger Medical GmbHCCM2019-03-19
04250892905013JaegerJaeger Medical GmbHCCM2019-03-19
04250892905020JaegerJaeger Medical GmbHCCM2019-03-19
00810016250234MGC DiagnosticsMEDICAL GRAPHICS CORPORATIONCCM2019-02-22
00810016250418MGC DiagnosticsMEDICAL GRAPHICS CORPORATIONCCM2019-02-22
00810016250241MGC DiagnosticsMEDICAL GRAPHICS CORPORATIONCCM2019-02-22
04250892902692JaegerJaeger Medical GmbHCCM2019-01-24
04250892902708JaegerJaeger Medical GmbHCCM2019-01-24
14250892902460JaegerJaeger Medical GmbHCCM2018-09-30
14250892902507JaegerJaeger Medical GmbHCCM2018-09-21
14250892902521JaegerJaeger Medical GmbHCCM2018-09-21