FDA.reportPublic FDA data

Jaeger

Primary DI
14250892907069
Brand
Jaeger
Company
Jaeger Medical GmbH
Model
852760
Catalog number
852760
Device description
Squeeze Jacket, size XXS, colour yellow
Published
2025-08-14
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
BZCCalculator, Pulmonary Function Data
CCMPlethysmograph, Pressure

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BZCCalculator, Pulmonary Function DataAnesthesiology2
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
14250892907069PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1425089290706914250892907069

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@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
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
04250892908823JaegerJaeger Medical GmbHCCM2025-11-24
04250892908823JaegerJaeger Medical GmbHBZC2025-11-24
04250892908861JaegerJaeger Medical GmbHBZC2025-11-24
04250892908984JaegerJaeger Medical GmbHBZC2025-11-24
04250892908991JaegerJaeger Medical GmbHBZC2025-11-24
14250892908905JaegerJaeger Medical GmbHBZC2025-11-24
14250892908905JaegerJaeger Medical GmbHCCM2025-11-24
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
04250892907345JaegerJaeger Medical GmbHBZC2025-10-31
04250892908304JaegerJaeger Medical GmbHBZC2025-10-31
04250892908311JaegerJaeger Medical GmbHBZC2025-10-31
04250892908328JaegerJaeger Medical GmbHBZC2025-10-31
04250892908427JaegerJaeger Medical GmbHBZC2025-10-31
04250892908779JaegerJaeger Medical GmbHBZC2025-10-31
04250892908786JaegerJaeger Medical GmbHBZC2025-10-31
04250892908793JaegerJaeger Medical GmbHBZC2025-10-31
04250892908809JaegerJaeger Medical GmbHBZC2025-10-31
14250892907335JaegerJaeger Medical GmbHBZC2025-08-21
34250892908169JaegerJaeger Medical GmbHBZC2025-08-18
34250892908176JaegerJaeger Medical GmbHBZC2025-08-18