FDA.reportPublic FDA data

APOTECA

Primary DI
05060304050243
Brand
APOTECA
Company
AEA SRL
Model
APOTECAped
Device description
Automatic system for compouding of non-hazardous drugs for pedriatic patients
Published
2018-05-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
NEPSystem/Device, Pharmacy Compounding

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NEPSystem/Device, Pharmacy CompoundingGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060304050243PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060304050243050603040502435060304050243

GMDN Terms#

Term, Definition table
TermDefinition
Pharmaceutical fluid-dispensing systemA assembly of devices used in a hospital and/or other healthcare facility to dispense fluids by combining in a given ratio several liquid components from a set of source containers into a container with the final product (i.e., it compounds drugs according to a specified medical prescription). It is typically a mains electricity (AC-powered) automated or semi-automated device that includes a set of standardized source liquid containers each attached with tubes to a compounding device which output is in turn attached to the final liquid container. It may also include a control panel to facilitate the introduction of manual or bar-coded mixing and/or checking instructions.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
429415227
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05060304050960APOTECAASN-05-B-NCE2022-03-16
05060304050977APOTECAASN-20-B-NCE2022-03-16
05060304050984APOTECAASN-50-B-NCE2022-03-16
05060304050991APOTECAASN-05-K-NCE2022-03-16
05060304051004APOTECAASN-20-K-NCE2022-03-16
05060304051011APOTECAASN-50-K-NCE2022-03-16
05060304050250APOTECAsyringeAPOTECAsyringe2021-03-01
05060304050823APOTECAS Dispensing LineSDL-01-STD2021-03-01
05060304050106APOTECAADY1100C2016-07-13
05060304050113APOTECAADY1200C2016-07-13
05060304050120APOTECAADY1100CF2016-07-13
05060304050137APOTECAADY1200CF2016-07-13
05060304050007APOTECAASN-032016-07-13
05060304050014APOTECAASN-052016-07-13
05060304050021APOTECAASN-102016-07-13
05060304050038APOTECAASN-202016-07-13
05060304050045APOTECAASN-502016-07-13
05060304050182APOTECAAPOTECAchemo2016-07-13
05060304050199APOTECAAPOTECAunit2016-07-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00887709170995ICU Medical, Inc.ICU MEDICAL, INC.NEP2026-06-02
00887709098602ICU Medical, Inc.ICU MEDICAL, INC.NEP2026-05-28
00887709166288ICU Medical, Inc.ICU MEDICAL, INC.NEP2026-04-16
00887709166295ICU Medical, Inc.ICU MEDICAL, INC.NEP2026-04-16
00887709166318ICU Medical, Inc.ICU MEDICAL, INC.NEP2026-04-16
00887709170988ICU Medical, Inc.ICU MEDICAL, INC.NEP2026-04-16
00887709127371ICU Medical, Inc.ICU MEDICAL, INC.NEP2026-04-01
00887709127388ICU Medical, Inc.ICU MEDICAL, INC.NEP2026-04-01
00887709127395ICU Medical, Inc.ICU MEDICAL, INC.NEP2026-04-01
00887709127432ICU Medical, IncICU MEDICAL, INC.NEP2026-04-01
00887709125995ICU Medical, Inc.ICU MEDICAL, INC.NEP2026-01-12
00887709167216ICU Medical, Inc.ICU MEDICAL, INC.NEP2025-10-20
00860001977356OnsetOnpharma CompanyNEP2025-09-19
00085412169286DUO-VENTBaxter Healthcare SANEP2025-03-20
50085412169281DUO-VENTBaxter Healthcare SANEP2025-03-20
00860006285043IVX ManagerOmnicell, Inc.NEP2024-05-10
00840619054908DianaTM Automated Drug Compounding SystemICU MEDICAL, INC.NEP2024-02-20
00840619065058DianaTM Automated Drug Compounding SystemICU MEDICAL, INC.NEP2024-02-20
00840619089894DianaTM Automated Drug Compounding SystemICU MEDICAL, INC.NEP2024-02-20
00840619090876DianaTM Automated Drug Compounding SystemICU MEDICAL, INC.NEP2024-02-20
00840619091590DianaTM Automated Drug Compounding SystemICU MEDICAL, INC.NEP2024-02-20
00850033629408Acta MedicalActa Medical LLCNEP2024-02-14
00860006285036IVX CloudOmnicell, Inc.NEP2024-01-10
08426314948258GRI-FILLLABORATORIOS GRIFOLS SANEP2023-07-19
00887709125117DianaTM Compounding Workflow SystemICU MEDICAL, INC.NEP2023-04-10
00887709125124DianaTM Compounding Workflow SystemICU MEDICAL, INC.NEP2023-04-10
00887709125131DianaTM Compounding Workflow SystemICU MEDICAL, INC.NEP2023-04-10
00887709125735DianaTM Compounding Workflow SystemICU MEDICAL, INC.NEP2023-04-10
00887709126497DianaTM Compounding Workflow SystemICU MEDICAL, INC.NEP2023-04-10
00887709126589DianaTM Compounding Workflow SystemICU MEDICAL, INC.NEP2023-04-10