APOTECA

Primary DI
05060304050014
Brand
APOTECA
Company
AEA SRL
Model
ASN-05
Device description
Pharmacy compounding dosing device
Published
2016-07-13
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
FMFSyringe, Piston

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMFSyringe, PistonGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K132011000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K132011000APOTECA DUG COMPOUNDING DOSING DEVICE,APOTECA I.V. TRANSFER SETAea Srl2014-03-21FMF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060304050014PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060304050014050603040500145060304050014

GMDN Terms#

Term, Definition table
TermDefinition
Hazardous fluid syringeA sterile device designed to promote the safe (leak-free) handling of fluids and medications that are potentially hazardous or cytotoxic, such as those used for chemotherapy, radioactive isotopes, or blood products. It consists of a calibrated hollow barrel (cylinder) connected to a needle-free port (valve), and a moveable plunger used to aspirate and expel the fluid into and out of the cylinder. It is typically made of plastic and silicone materials and used for drug/fluid preparation, for their administration to the patient, and for waste handling of the expended device. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
429415227
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration 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
05060304050021APOTECAASN-102016-07-13
05060304050038APOTECAASN-202016-07-13
05060304050045APOTECAASN-502016-07-13
05060304050243APOTECAAPOTECAped2018-05-22
05060304050182APOTECAAPOTECAchemo2016-07-13
05060304050199APOTECAAPOTECAunit2016-07-13

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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09347144015004Metier MedicalMETIER MEDICAL LTDFMF2026-10-12
09347144016186Metier MedicalMETIER MEDICAL LTDFMF2026-10-12
09347144016216Metier MedicalMETIER MEDICAL LTDFMF2026-10-12
20612479288496McKessonMCKESSON MEDICAL-SURGICAL INC.FMF2026-10-08
20612479288526McKessonMCKESSON MEDICAL-SURGICAL INC.FMF2026-10-08
10304040193843Henry ScheinHENRY SCHEIN, INC.FMF2026-10-05
10304040193850Henry ScheinHENRY SCHEIN, INC.FMF2026-10-05
10304040193867Henry ScheinHENRY SCHEIN, INC.FMF2026-10-05
10304040193874Henry ScheinHENRY SCHEIN, INC.FMF2026-10-05
10304040193881Henry ScheinHENRY SCHEIN, INC.FMF2026-10-05
10304040193898Henry ScheinHENRY SCHEIN, INC.FMF2026-10-05
10304040194109Henry ScheinHENRY SCHEIN, INC.FMF2026-10-05
10304040194116Henry ScheinHENRY SCHEIN, INC.FMF2026-10-05
10304040194208Henry ScheinHENRY SCHEIN, INC.FMF2026-10-05
10304040194215Henry ScheinHENRY SCHEIN, INC.FMF2026-10-05
10304040194222Henry ScheinHENRY SCHEIN, INC.FMF2026-10-05
10304040194239Henry ScheinHENRY SCHEIN, INC.FMF2026-10-05
10304040194246Henry ScheinHENRY SCHEIN, INC.FMF2026-10-05
10304040194253Henry ScheinHENRY SCHEIN, INC.FMF2026-10-05
10304040194260Henry ScheinHENRY SCHEIN, INC.FMF2026-10-05
10304040194277Henry ScheinHENRY SCHEIN, INC.FMF2026-10-05
10304040194284Henry ScheinHENRY SCHEIN, INC.FMF2026-10-05
10304040194291Henry ScheinHENRY SCHEIN, INC.FMF2026-10-05
10304040194307Henry ScheinHENRY SCHEIN, INC.FMF2026-10-05
10304040194314Henry ScheinHENRY SCHEIN, INC.FMF2026-10-05
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