FDA.reportPublic FDA data

EXACTAMIX

Primary DI
08033718000934
Brand
EXACTAMIX
Company
HAEMOTRONIC SPA
Model
E3002OD5
Catalog number
5030020516
Device description
250 mL ExactaMix EVA multiple (5 bags)
Published
2022-03-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
KPEContainer, I.V.

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KPEContainer, I.V.General Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
18033718000931PackageGS15In Commercial Distribution
28033718000938PackageGS110In Commercial Distribution
08033718000934PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1803371800093118033718000931
2803371800093828033718000938
08033718000934080337180009348033718000934

GMDN Terms#

Term, Definition table
TermDefinition
Intravenous administration bag/bottleAn empty pouch or bottle made of plastic or glass intended to contain a fluid (e.g., saline, medication) for intravenous (IV) administration; some types may in addition be intended for enteral feeding applications. It may be composed of one or more chambers and might be provided with a short length of tubing; however, it does not include other associated items (e.g., clamp, spike) [i.e., not an IV administration set] and is not intended to be directly connected to the IV catheter. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
430857771
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08033718000903EXACTAMIX E3002OD50300200162020-11-20
08033718000910EXACTAMIX E3005OD50300500162020-11-20
08033718000958EXACTAMIX E3010OD50301000162021-08-06
08033718000972EXACTAMIX E3020OD50302000162020-11-20
08033718000989EXACTAMIX E3030OD50303000162021-10-05
08033718000996EXACTAMIX E3040OD50304000162021-10-05
08033718001009EXACTAMIX E3050OD50305000162021-10-05
08033718000941EXACTAMIX E3005OD550300505162022-03-25
08033718000965EXACTAMIX E3010OD550301005162022-03-25
08033718001061VITAVITA2001R50005000162022-03-25
08033718001078VITAVITA2002R50010000162022-03-25
08033718001085VITAVITA2003R50025000162022-03-25
08033718001108EXACTAMIX E3001OD50300102162022-03-25
18033718001068VITAVITA2001R50005000162022-03-25
18033718001075VITAVITA2002R50010000162022-03-25
18033718001082VITAVITA2003R50025000162022-03-25
28033718001102EXACTAMIX E3001OD50300102162022-03-25
18033718000986EXACTAMIX E3030OD50303000162021-10-05
18033718000993EXACTAMIX E3040OD50304000162021-10-05
18033718001006EXACTAMIX E3050OD50305000162021-10-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
18859299123612eZSURE™EPIC INTERNATIONAL(THAILAND) COMPANY LIMITEDKPE2026-04-10
18859299123629eZSURE™EPIC INTERNATIONAL(THAILAND) COMPANY LIMITEDKPE2026-04-10
18859299123636eZSURE™EPIC INTERNATIONAL(THAILAND) COMPANY LIMITEDKPE2026-04-10
18859299124589eZSURE™EPIC INTERNATIONAL(THAILAND) COMPANY LIMITEDKPE2026-04-10
08056209145105EVA TPN BAGSVALMED SRLKPE2026-02-02
08056209145112EVA TPN BAGSVALMED SRLKPE2026-02-02
18033737862282EVA TPN BagsVALMED SRLKPE2025-12-31
10748426139726Medline-MicrotekMicrotek Medical LLCKPE2025-10-10
10748426139672Medline-MicrotekMicrotek Medical LLCKPE2025-10-08
10748426139719Medline-MicrotekMicrotek Medical LLCKPE2025-10-08
18859299136131eZSURE™EPIC INTERNATIONAL(THAILAND) COMPANY LIMITEDKPE2025-09-11
18859299136148eZSURE™EPIC INTERNATIONAL(THAILAND) COMPANY LIMITEDKPE2025-09-11
18859299136155eZSURE™EPIC INTERNATIONAL(THAILAND) COMPANY LIMITEDKPE2025-09-11
20192253056706ChemoPlusCardinal Health 200, LLCKPE2025-08-22
20192253056713ChemoPlusCardinal Health 200, LLCKPE2025-08-22
18859299136179eZSURE™EPIC INTERNATIONAL(THAILAND) COMPANY LIMITEDKPE2025-07-31
18859299136032eZSURE™EPIC INTERNATIONAL(THAILAND) COMPANY LIMITEDKPE2025-06-06
18859299136049eZSURE™EPIC INTERNATIONAL(THAILAND) COMPANY LIMITEDKPE2025-06-06
18859299136063eZSURE™EPIC INTERNATIONAL(THAILAND) COMPANY LIMITEDKPE2025-06-06
18859299136070eZSURE™EPIC INTERNATIONAL(THAILAND) COMPANY LIMITEDKPE2025-06-06
18859299136087eZSURE™EPIC INTERNATIONAL(THAILAND) COMPANY LIMITEDKPE2025-06-06
18859299136117eZSURE™EPIC INTERNATIONAL(THAILAND) COMPANY LIMITEDKPE2025-06-06
10612479272122McKessonMCKESSON MEDICAL-SURGICAL INC.KPE2024-08-21
10612479272146McKessonMCKESSON MEDICAL-SURGICAL INC.KPE2024-08-21
10612479272160McKessonMCKESSON MEDICAL-SURGICAL INC.KPE2024-08-21
10612479272184McKessonMCKESSON MEDICAL-SURGICAL INC.KPE2024-08-21
10612479272207McKessonMCKESSON MEDICAL-SURGICAL INC.KPE2024-08-21
10612479272221McKessonMCKESSON MEDICAL-SURGICAL INC.KPE2024-08-21
10612479272245McKessonMCKESSON MEDICAL-SURGICAL INC.KPE2024-08-21
10612479272269McKessonMCKESSON MEDICAL-SURGICAL INC.KPE2024-08-21