APOTECA

Primary DI
05060304050106
Brand
APOTECA
Company
AEA SRL
Model
ADY1100C
Device description
I.V. Transfer Set
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
LHISet, I.V. Fluid Transfer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LHISet, I.V. Fluid TransferGeneral 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
05060304050106PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060304050106050603040501065060304050106

GMDN Terms#

Term, Definition table
TermDefinition
Fluid transfer set, general-purposeA collection of sterile devices and supplies designed to transfer several types of medical fluids (e.g., drugs, vaccines, blood, and solutions) between a first container(s) [e.g., a vial(s)] and a second container [e.g., an intravenous (IV) bag]. It is available in a variety of configurations and typically includes tubes, connectors, spike(s), syringes, and caps. 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
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

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