FDA.reportPublic FDA data

GRI-BAG

Primary DI
28426314391478
Brand
GRI-BAG
Company
LABORATORIOS GRIFOLS SA
Model
500
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.
Published
2021-10-26
Public version status
New
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
KPEContainer, I.V.

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KPEContainer, I.V.General 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
28426314391478PackageGS120In Commercial Distribution
08426314575690PreviousGS10
08426314391474PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
2842631439147828426314391478
08426314575690084263145756908426314575690
08426314391474084263143914748426314391474

GMDN Terms#

Term, Definition table
TermDefinition
Compounding transfer setA collection of sterile items typically used in the clinical pharmacy or a manufacturing plant to provide a sterile fluid path for the compounding (mixing) of different multi-ingredient solutions from multiple source containers into a final suitable container. It is typically available in a variety of configurations (e.g., as a 6-lead or a 9-lead set) and includes, e.g., tubes, connectors, spikes. This device may also be used for intravenous (IV) solution compounding. 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
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
18859299123612eZSURE™EPIC INTERNATIONAL(THAILAND) COMPANY LIMITEDKPE2026-04-10
18859299123629eZSURE™EPIC INTERNATIONAL(THAILAND) COMPANY LIMITEDKPE2026-04-10
18859299123636eZSURE™EPIC INTERNATIONAL(THAILAND) COMPANY LIMITEDKPE2026-04-10
18859299124589eZSURE™EPIC INTERNATIONAL(THAILAND) COMPANY LIMITEDKPE2026-04-10
08056209145105EVA TPN BAGSVALMED SRLKPE2026-02-02
08056209145112EVA TPN BAGSVALMED SRLKPE2026-02-02
18033737862282EVA TPN BagsVALMED SRLKPE2025-12-31
10748426139726Medline-MicrotekMicrotek Medical LLCKPE2025-10-10
10748426139672Medline-MicrotekMicrotek Medical LLCKPE2025-10-08
10748426139719Medline-MicrotekMicrotek Medical LLCKPE2025-10-08
18859299136131eZSURE™EPIC INTERNATIONAL(THAILAND) COMPANY LIMITEDKPE2025-09-11
18859299136148eZSURE™EPIC INTERNATIONAL(THAILAND) COMPANY LIMITEDKPE2025-09-11
18859299136155eZSURE™EPIC INTERNATIONAL(THAILAND) COMPANY LIMITEDKPE2025-09-11
20192253056706ChemoPlusCardinal Health 200, LLCKPE2025-08-22
20192253056713ChemoPlusCardinal Health 200, LLCKPE2025-08-22
18859299136179eZSURE™EPIC INTERNATIONAL(THAILAND) COMPANY LIMITEDKPE2025-07-31
18859299136032eZSURE™EPIC INTERNATIONAL(THAILAND) COMPANY LIMITEDKPE2025-06-06
18859299136049eZSURE™EPIC INTERNATIONAL(THAILAND) COMPANY LIMITEDKPE2025-06-06
18859299136063eZSURE™EPIC INTERNATIONAL(THAILAND) COMPANY LIMITEDKPE2025-06-06
18859299136070eZSURE™EPIC INTERNATIONAL(THAILAND) COMPANY LIMITEDKPE2025-06-06
18859299136087eZSURE™EPIC INTERNATIONAL(THAILAND) COMPANY LIMITEDKPE2025-06-06
18859299136117eZSURE™EPIC INTERNATIONAL(THAILAND) COMPANY LIMITEDKPE2025-06-06
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