FDA.reportPublic FDA data

SW ASCENT 2.4.0 DOWNLOAD

Primary DI
00810016252269
Brand
SW ASCENT 2.4.0 DOWNLOAD
Company
MEDICAL GRAPHICS CORPORATION
Model
148025-502
Device description
SW ASCENT 2.4.0 DOWNLOAD Cardiorespiratory Diagnostic software
Published
2026-06-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810016252269PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810016252269008100162522698100162522690810016252269

GMDN Terms#

Term, Definition table
TermDefinition
Pulmonary function analysis software, non-interpretiveA software program intended to be used on a non-medical computerized device for use by a healthcare professional to aid analysis of data captured during pulmonary function testing/analysis (e.g., spirometry, plethysmography, carbon dioxide breath analysis). It is intended to produce charts, graphs, and store data; it is not intended to interpret results. It is not intended for respiratory sound analysis.

Regulatory Flags#

DUNS number
094045622
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810016252252Assy Meridian Series790708-0012026-06-10
00810016252283Fenom Flo™701098-001800861-0012026-06-10
00810016252290Fenom Flo™148029-5022026-06-10
00810016252313SW Ascent 2.5 Download148033-5022026-06-10
00810016252320Fenom Flo™155235-0012026-06-10
00810016250555Medical Graphics147999-0042023-07-18
00810016250579Medical Graphics147999-5022023-07-18
00810016250616Medical Graphics536018-001 2023-06-14
00810016250340MGC Diagnostics762042-003800704-0032019-02-22
00810016250357MGC Diagnostics762042-904800704-9042019-02-22
00810016250364MGC Diagnostics762042-905800704-9052019-02-22
B3687620420030MGC Diagnostics762042-003800704-0032017-01-12
B3687620429040MGC Diagnostics762042-904800704-9042018-06-18
B3687620429050MGC Diagnostics762042-905800704-9052018-06-18
B368700023905MGC Diagnostics700023-905700023-9052016-09-09
B3687000239060MGC Diagnostics700023-9062018-06-18
B368800810001MGC Diagnostics800810-001800810-0012016-09-09
B368800810011MGC Diagnostics800810-011800810-0112016-09-09
B3688008100210MGC Diagnostics800810-0212018-06-18
B3688008100310MGC Diganostics800810-0312018-06-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810016252313SW Ascent 2.5 DownloadMEDICAL GRAPHICS CORPORATIONBTY2026-06-10
00810016252313SW Ascent 2.5 DownloadMEDICAL GRAPHICS CORPORATIONBZC2026-06-10
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 GmbHBTY2025-10-31