FDA.reportPublic FDA data

Jaeger

Primary DI
04250892908700
Brand
Jaeger
Company
Jaeger Medical GmbH
Model
375119-13
Catalog number
375119-13
Device description
APS Pro SA
Published
2025-11-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
BZCCalculator, Pulmonary Function Data

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K001502000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K001502000AEROSOL PROVOCATION SYSTEM APS PRO, MODEL APS PROErich Jaeger GmbH2000-07-12BZC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04250892908700PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04250892908700042508929087004250892908700

GMDN Terms#

Term, Definition table
TermDefinition
Therapeutic agent nebulizer, benchtopAn assembly of devices intended to be used in the home and clinical to aerosolize medication/fluids, by non-heat-dependent means (i.e., not a vaporizer), for inhalation by a patient, typically to treat/manage a respiratory disorder [e.g., chronic obstructive pulmonary disease (COPD), cystic fibrosis (CF)]. It includes an electrically-powered generator (ultrasonic and/or compressor jet type), a reservoir, and a nebulizing chamber where the nebulization of the medicine usually occurs. Disposable devices (e.g., tubing, mask, mouthpiece) are attached to the device for inhalation. It is designed to be placed on a benchtop/flat surface during use.

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
+499314972127techsupport.int@jaegerrdx.com

Regulatory Flags#

DUNS number
329769991
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04250892907352SentrySuite Software3.20V-7709652025-11-24
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
14250892908936Jaeger7068237068232025-11-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04250892907352SentrySuite SoftwareJaeger Medical GmbHBZC2025-11-24
04250892908717JaegerJaeger Medical GmbHBZC2025-11-24
04250892908731JaegerJaeger Medical GmbHBZC2025-11-24
04250892908816JaegerJaeger Medical GmbHBZC2025-11-24
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
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
34250892908190JaegerJaeger Medical GmbHBZC2025-08-18
34250892908220JaegerJaeger Medical GmbHBZC2025-08-18
34250892908237JaegerJaeger Medical GmbHBZC2025-08-18