FDA.reportPublic FDA data

GRI-BAG

Primary DI
08426314580816
Brand
GRI-BAG
Company
LABORATORIOS GRIFOLS SA
Model
1000 AP
Device description
GRI-BAG is a single-use, non-pyrogenic flexible empty container with incorporated 0.2 µ.m filter. It is supplied sterile in sealed peel-pack pouches and isavailable in volume capacities of 100 ml, 250 ml, 500 ml and 1000 ml. The GRI-BAG models have a twist-off valve output connector whereas the GRIBAGAP models have a conus vial output connector.
Published
2017-04-05
Public version status
Update
Distribution status
Not 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
FPBFilter, Infusion Line
KPEContainer, I.V.
NEPSystem/Device, Pharmacy Compounding

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FPBFilter, Infusion LineGeneral Hospital2
KPEContainer, I.V.General Hospital2
NEPSystem/Device, Pharmacy CompoundingGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K033916000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K033916000GRI-BAG, GRI-BAG APLaboratorios Grifols, S.A.2003-12-30KPE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
28426314580810PackageGS115Not in Commercial Distribution
08426314580816PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
2842631458081028426314580810
08426314580816084263145808168426314580816

GMDN Terms#

Term, Definition table
TermDefinition
Intravenous administration bag/bottleAn empty pouch or bottle made of plastic or glass intended to contain a fluid (e.g., saline, medication) for intravenous (IV) administration; some types may in addition be intended for enteral feeding applications. It may be composed of one or more chambers and might be provided with a short length of tubing; however, it does not include other associated items (e.g., clamp, spike) [i.e., not an IV administration set] and is not intended to be directly connected to the IV catheter. This is a single-use device.

Regulatory Flags#

DUNS number
463720681
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
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
08426314948258GRI-FILL-2023-07-19
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

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
08056209145105EVA TPN BAGSVALMED SRLKPE2026-02-02
08056209145112EVA TPN BAGSVALMED SRLKPE2026-02-02
10748426139726Medline-MicrotekMicrotek Medical LLCKPE2025-10-10
10748426139672Medline-MicrotekMicrotek Medical LLCKPE2025-10-08
10748426139719Medline-MicrotekMicrotek Medical LLCKPE2025-10-08
10612479272122McKessonMCKESSON MEDICAL-SURGICAL INC.KPE2024-08-21
10612479272146McKessonMCKESSON MEDICAL-SURGICAL INC.KPE2024-08-21
10612479272160McKessonMCKESSON MEDICAL-SURGICAL INC.KPE2024-08-21
10612479272184McKessonMCKESSON MEDICAL-SURGICAL INC.KPE2024-08-21
10612479272207McKessonMCKESSON MEDICAL-SURGICAL INC.KPE2024-08-21
10612479272221McKessonMCKESSON MEDICAL-SURGICAL INC.KPE2024-08-21
10612479272245McKessonMCKESSON MEDICAL-SURGICAL INC.KPE2024-08-21
10612479272269McKessonMCKESSON MEDICAL-SURGICAL INC.KPE2024-08-21
10612479272283McKessonMCKESSON MEDICAL-SURGICAL INC.KPE2024-08-21
10612479272306McKessonMCKESSON MEDICAL-SURGICAL INC.KPE2024-08-21
10612479272320McKessonMCKESSON MEDICAL-SURGICAL INC.KPE2024-08-21
10612479272344McKessonMCKESSON MEDICAL-SURGICAL INC.KPE2024-08-21
10612479272368McKessonMCKESSON MEDICAL-SURGICAL INC.KPE2024-08-21
10612479272382McKessonMCKESSON MEDICAL-SURGICAL INC.KPE2024-08-21
08056209144009EVA TPN BagsVALMED SRLKPE2024-06-29
08056209144016EVA TPN BagsVALMED SRLKPE2024-06-29
08056209144023EVA TPN BagsVALMED SRLKPE2024-06-29
08056209144030EVA TPN BagsVALMED SRLKPE2024-06-29
08056209144047EVA TPN BagsVALMED SRLKPE2024-06-29
08056209144054EVA TPN BagsVALMED SRLKPE2024-06-29
08056209144061EVA TPN BagsVALMED SRLKPE2024-06-29
08056209144078EVA TPN BagsVALMED SRLKPE2024-06-29
08056209143989EVA TPN BagsVALMED SRLKPE2024-01-11