FDA.reportPublic FDA data

MGC Diagnostics

Primary DI
B368830005002
Brand
MGC Diagnostics
Company
MEDICAL GRAPHICS CORPORATION
Model
830005-002
Catalog number
830005-002
Device description
Elite Platinum DX
Published
2016-12-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
CCMPlethysmograph, Pressure

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CCMPlethysmograph, PressureAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K943259000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K9432590001085 ULTIMATE E PLETHYSMOGRAPHMedical Graphics Corp.1995-04-10CCM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810016250418PrimaryGS10
B368830005002PrimaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810016250418008100162504188100162504180810016250418

GMDN Terms#

Term, Definition table
TermDefinition
Whole-body plethysmographA graphic recorder designed for determining and registering airway resistance and thoracic gas volume to assess pulmonary function. It includes an airtight body chamber and transducers that allow the recording of chamber pressure versus airflow, and chamber pressure versus mouth pressure, to determine the airway resistance. Thoracic gas volume is typically determined by recording the chamber and airway pressures simultaneously with the airway open and with the airway occluded. It may also be possible to determine the instantaneous flow by recording the pulmonary capillary blood flow with the device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
094045622
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
B368800820001MGC Diagnostics800820-001800820-0012016-09-07
B368800820011MGC Diagnostics800820-011800820-0112016-09-09
B3688008200210MGC Diagnostics800820-0212018-06-18
B3688008200310MGC Diagnostics800820-0312018-06-18
B368800830001MGC Diagnostics800830-001800830-0012016-09-09

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
14250892906178VyaireJaeger 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