FDA.reportPublic FDA data

NA

Primary DI
00763000561826
Brand
NA
Company
MEDTRONIC, INC.
Model
550-11
Device description
CALCIUM CHLORIDE 5 ML 550-11
Published
2023-03-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
GGNPlasma, coagulation control

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GGNPlasma, Coagulation ControlHematology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00763000561826PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00763000561826007630005618267630005618260763000561826

GMDN Terms#

Term, Definition table
TermDefinition
Multiple coagulation factor IVD, controlA material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative determination of one or multiple coagulation factors, coagulation intermediates and/or their activated components in a clinical specimen.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume5Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius25 Degrees Celsius
Storage Environment Temperature35.6 Degrees Fahrenheit77 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-8766Corporate.UDI@medtronic.com

Regulatory Flags#

DUNS number
006261481
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00199309001242Percept™ PC BrainSense™B352002026-08-07
00199309001259Percept™ RCB353002026-08-07
00824846005445NA12T76R12026-07-30
00824846005469NABB2Q31R112026-07-30
00824846005667NABB9R33R162026-07-30
00824846006022NABB12S36R2026-07-30
00824846007944NABB12W03R12026-07-30
00613994746627ATTAIN SELECT™ II624890D022016-07-16
00763000862336MyCareLink™249552026-07-26
00763000060374LINQ II™LNQ222020-07-18
00763000422615SYNCHROMED®II8637-402021-04-11
00763000634094SYNCHROMED® II8637-202022-08-11
00763000634100SYNCHROMED® II8637-402022-08-11
00643169508149SYNCHROMED® II8637-202016-04-27
00643169508156SYNCHROMED® II8637-402016-04-27
00643169630505SYNCHROMED® II8637-202018-08-17
00643169630512SYNCHROMED® II8637-402018-08-17
00643169100824SYNCHROMED ® II8637-402016-04-27
00643169100831SYNCHROMED ® II8637-202016-04-27
00199150084036MiniMed Flex Starter KitMMT-8076B2026-07-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
050700024203855-PLASMA Bivalirudin Control5-Diagnostics LtdGGN2026-04-02
08426951011131HemosIL CL Multi-Ab ControlsINSTRUMENTATION LABORATORY COMPANYGGN2025-10-30
00815696021327George King Heparin Control Plasma GEORGE KING BIO-MEDICAL, INCGGN2025-07-11
08718734962724CueSee® CoagEurotrol B.V.GGN2025-04-08
08718734962731CueSee® CoagEurotrol B.V.GGN2025-04-08
08718734962748CueSee® CoagEurotrol B.V.GGN2025-04-08
08718734962755CueSee® CoagEurotrol B.V.GGN2025-04-08
08718734962762CueSee® CoagEurotrol B.V.GGN2025-04-08
08718734962779CueSee® CoagEurotrol B.V.GGN2025-04-08
08718734962786CueSee® CoagEurotrol B.V.GGN2025-04-08
08718734962793CueSee® CoagEurotrol B.V.GGN2025-04-08
08718734962809CueSee® CoagEurotrol B.V.GGN2025-04-08
08718734962816CueSee® CoagEurotrol B.V.GGN2025-04-08
09360136000055Xprecia™ Systems PT ControlsUNIVERSAL BIOSENSORS PTY LTDGGN2024-08-27
08430793242998HEMOSIL RIVAROXABAN CONTROLSINSTRUMENTATION LABORATORY COMPANYGGN2024-07-22
00630414639840INNOVANCE Heparin UF Control 2Siemens Healthcare Diagnostics Products GmbHGGN2024-03-25
00630414639857INNOVANCE Heparin LMW Control 2Siemens Healthcare Diagnostics Products GmbHGGN2024-03-25
00630414639949INNOVANCE Heparin UF Control 1Siemens Healthcare Diagnostics Products GmbHGGN2024-03-25
00630414639956INNOVANCE Heparin LMW Control 1Siemens Healthcare Diagnostics Products GmbHGGN2024-03-25
00630414640280Dade Ci-Trol Coagulation Control Level 2Siemens Healthcare Diagnostics Products GmbHGGN2024-03-25
00630414640426Dade Ci-Trol Coagulation Control Level 3Siemens Healthcare Diagnostics Products GmbHGGN2024-03-25
00630414640624ProC Control PlasmaSiemens Healthcare Diagnostics Products GmbHGGN2024-03-25
00630414229522INNOVANCE Heparin UF Control 2Siemens Healthcare Diagnostics Products GmbHGGN2024-03-25
00630414229546INNOVANCE Heparin LMW Control 2Siemens Healthcare Diagnostics Products GmbHGGN2024-03-25
00630414229515INNOVANCE Heparin UF Control 1Siemens Healthcare Diagnostics Products GmbHGGN2024-03-25
00630414229539INNOVANCE Heparin LMW Control 1Siemens Healthcare Diagnostics Products GmbHGGN2024-03-25
00842768019463Dade Ci-Trol Coagulation Control Level 2Siemens Healthcare Diagnostics Products GmbHGGN2024-03-25
00842768019456Dade Ci-Trol Coagulation Control Level 3Siemens Healthcare Diagnostics Products GmbHGGN2024-03-25
00842768019005ProC Control PlasmaSiemens Healthcare Diagnostics Products GmbHGGN2024-03-25
00630414640747Control Plasma N Siemens Healthcare Diagnostics Products GmbHGGN2024-02-19