FDA.reportPublic FDA data

GRI-FILL

Primary DI
08426314948258
Brand
GRI-FILL
Company
LABORATORIOS GRIFOLS SA
Model
-
Device description
GRI-FILL is a pharmacy compounding device (PCD) and as such is an electromechanical device controlled by software intended to deliver a specified concentration or proportion of ingredients different from the initial solutions.
Published
2023-07-19
Public version status
Update
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
08426314948258PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08426314948258084263149482588426314948258

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
463719725
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
08426314391399GRI-BAG1002021-10-26
08426314391412GRI-BAG2502021-10-26
08426314391474GRI-BAG5002021-10-26
08426314391481GRI-BAG10002021-10-26
08426314778770GRI-FILL 6 to1 Set-2021-10-25
08426314387972GRI-FILL PERISTALTIC SET-2018-11-21
08426314575768GRI-FILL 2 Ways SetGRI-FILL 2 Ways Set2022-03-15
08426314601146SET GRI-FILL 3.02 ways2017-01-02
08426314734561QUICKPINQUICKPIN2017-04-05
08426314792578FLEBOSETDOUBLE2017-04-05
38426314734562QUICKPINQUICKPIN2017-04-05
28426314391393GRI-BAG1002021-10-26
28426314391416GRI-BAG2502021-10-26
28426314391478GRI-BAG5002021-10-26
28426314391485GRI-BAG10002021-10-26
28426314778774GRI-FILL 6 to1 Set-2021-10-25
08426314546836GRI-BAG1002017-01-02
08426314604031GRI-BAG2502017-04-05
08426314575683GRI-BAG10002017-04-05
08426314575690GRI-BAG5002017-04-05

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
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
00887709126596DianaTM Compounding Workflow SystemICU MEDICAL, INC.NEP2023-04-10