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

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
00810016252207SW Ascent 1.3.1147984-0012026-08-27
00810016252252Assy Meridian Series790708-0012026-06-10
00810016252269SW ASCENT 2.4.0 DOWNLOAD148025-5022026-06-10
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

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