FDA.reportPublic FDA data

Jaeger

Primary DI
14250892907656
Brand
Jaeger
Company
Jaeger Medical GmbH
Model
706134
Catalog number
706134
Device description
Double tube adapter with In/Ex-valve
Published
2025-07-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
BTYCalculator, Predicted Values, Pulmonary Function
BZCCalculator, Pulmonary Function Data

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BTYCalculator, Predicted Values, Pulmonary FunctionAnesthesiology2
BZCCalculator, Pulmonary Function DataAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K122699000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K122699000SENTRYSUITE PRODUCT LINECarefusion Germany 234 GmbH2012-11-19BTY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14250892907656PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1425089290765614250892907656

GMDN Terms#

Term, Definition table
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#

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@jaegerrdx.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
050991693321579100 VITALOGRAPH VitaloLAB+VITALOGRAPH (IRELAND) LIMITEDBTY2026-06-02
00850000967328SpiroLoopCMI HEALTH INC.BTY2026-03-06
00850000967625SpiroLink 2 ProCMI HEALTH INC.BTY2026-03-06
04250892907352SentrySuite SoftwareJaeger Medical GmbHBZC2025-11-24
04250892908700JaegerJaeger Medical GmbHBZC2025-11-24
04250892908717JaegerJaeger Medical GmbHBZC2025-11-24
04250892908731JaegerJaeger Medical GmbHBZC2025-11-24
04250892908816JaegerJaeger Medical GmbHBZC2025-11-24
04250892908816JaegerJaeger Medical GmbHBTY2025-11-24
04250892908823JaegerJaeger Medical GmbHBZC2025-11-24
04250892908861JaegerJaeger Medical GmbHBZC2025-11-24
04250892908861JaegerJaeger Medical GmbHBTY2025-11-24
04250892908984JaegerJaeger Medical GmbHBZC2025-11-24
04250892908991JaegerJaeger Medical GmbHBZC2025-11-24
04250892909059JaegerJaeger Medical GmbHBTY2025-11-24
04250892909066JaegerJaeger Medical GmbHBTY2025-11-24
14250892908905JaegerJaeger Medical GmbHBZC2025-11-24
14250892908936JaegerJaeger Medical GmbHBZC2025-11-24
34250892909012JaegerJaeger Medical GmbHBZC2025-11-24
34250892909029JaegerJaeger Medical GmbHBZC2025-11-24
34250892908367JaegerJaeger Medical GmbHBZC2025-10-31
34250892908541JaegerJaeger Medical GmbHBZC2025-10-31
34250892908589JaegerJaeger Medical GmbHBZC2025-10-31
34250892908633JaegerJaeger Medical GmbHBTY2025-10-31
04250892907345JaegerJaeger Medical GmbHBZC2025-10-31
04250892908304JaegerJaeger Medical GmbHBZC2025-10-31
04250892908304JaegerJaeger Medical GmbHBTY2025-10-31
04250892908311JaegerJaeger Medical GmbHBZC2025-10-31
04250892908311JaegerJaeger Medical GmbHBTY2025-10-31
04250892908328JaegerJaeger Medical GmbHBZC2025-10-31