FDA.reportPublic FDA data

APOTECA

Primary DI
05060304050984
Brand
APOTECA
Company
AEA SRL
Model
ASN-50-B-NCE
Device description
Pharmacy compounding dosing device
Published
2022-03-16
Public version status
New
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
05060304050984PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060304050984050603040509845060304050984

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
No natural rubber latex
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
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
05060304050243APOTECAAPOTECAped2018-05-22
05060304050182APOTECAAPOTECAchemo2016-07-13
05060304050199APOTECAAPOTECAunit2016-07-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800045103061Feel Ject(FIS-054, U-100, 1.0cc, 31G x 6mm)Feel Tech Bio Co., Ltd.FMF2026-07-29
08800045105164Feel Ject(FIS-202, U-100, 0.3 cc, 29G x 12.7mm)Feel Tech Bio Co., Ltd.FMF2026-07-29
08800045105256Feel Ject(FIS-205, U-100, 0.3 cc, 31G x 8mm)Feel Tech Bio Co., Ltd.FMF2026-07-29
08800045105492Feel Ject(FIS-213, U-100, 1.0cc, 31G x 8mm)Feel Tech Bio Co., Ltd.FMF2026-07-29
08800045105614Feel Ject(FIS-217, U-100, 0.5 cc, 31G x 6mm)Feel Tech Bio Co., Ltd.FMF2026-07-29
00810131885045ION Non CervicalSurgentec, LLCFMF2026-07-28
00884450486955Merit Medical®Merit Medical Systems, Inc.FMF2026-07-25
10816336022275NC600300-ENFNEOCHILD, LLCFMF2026-07-23
10816336022282NC602000-ENFNEOCHILD, LLCFMF2026-07-23
10816336022442NC600100-ENFNEOCHILD, LLCFMF2026-07-23
00884450492888Merit Medical®Merit Medical Systems, Inc.FMF2026-07-22
10383017593015Ultra-Fine SAFETYEmbecta Medical II, LLCFMF2026-07-21
10383017593213Ultra-Fine SAFETYEmbecta Medical II, LLCFMF2026-07-21
10383017593411Ultra-Fine SAFETYEmbecta Medical II, LLCFMF2026-07-21
10383017593510Ultra-Fine SAFETYEmbecta Medical II, LLCFMF2026-07-21
10383017593718Ultra-Fine SAFETYEmbecta Medical II, LLCFMF2026-07-21
10383017844612Ultra-Fine SAFETYEmbecta Medical II, LLCFMF2026-07-21
10383017844711Ultra-Fine SAFETYEmbecta Medical II, LLCFMF2026-07-21
10383017844919Ultra-Fine SAFETYEmbecta Medical II, LLCFMF2026-07-21
18257200121076O-GENESISOrthofix US LLCFMF2026-07-17
18257200121083O-GENESISOrthofix US LLCFMF2026-07-17
05391530753944Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-03
05391530753951Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-03
05391530754217Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-03
05391530754620Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-03
05391530754699Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-03
05391530754941NuGen syringeDMC MEDICAL LIMITEDFMF2026-06-03
05391530754965NuGen syringeDMC MEDICAL LIMITEDFMF2026-06-03
05391530753968Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-02
05391530754088Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-02