FDA.reportPublic FDA data

GRI-BAG

Primary DI
28426314580810
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 is available 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 GRIBAG AP models have a conus vial output connector.
Published
2017-04-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
NEPSystem/Device, Pharmacy Compounding

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
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
28426314580810PackageGS115In 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
463720681
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
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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
08426314948258GRI-FILLLABORATORIOS GRIFOLS SANEP2023-07-19
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