FDA.reportPublic FDA data

Bulk Packaged ster. filtered WFI - 1L

Primary DI
05407013460282
Brand
Bulk Packaged ster. filtered WFI - 1L
Company
Lonza Verviers
Model
BESP1325P1SAM
Catalog number
BESP1325P1SAM
Published
2026-09-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
false

Product Codes#

Code, Name table
CodeName
PPMGeneral Purpose Reagent

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PPMGeneral Purpose ReagentPathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05407013460282PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05407013460282054070134602825407013460282

GMDN Terms#

Term, Definition table
TermDefinition
Ex vivo cell culture mediumA solution used for the ex-vivo culture of human-derived or non-human cells [e.g., T-lymphocytes, mesenchymal stem cells (MSCs), embryonic stem cells, induced pluripotent stem cells (iPSC)] or immortalised cell lines (e.g., HaCat, HeLa, HEK-293, cos-7, PC-12) intended for cell therapy applications. The solution contains a combination of nutrients, which may include amino acids, vitamins and organic salts that are vital for the growth and maintenance of the cell type/line. It is not intended for in vitro fertilization (IVF) or in vitro diagnostic applications.

Regulatory Flags#

DUNS number
370158847
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
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
05407013460206mRNA Buffer 103 : 1L Bag sampleBESP1810P1SAMBESP1810P1SAM2026-09-24
05407013460213mRNA Buffer 103 : 200L BagBESP1810P200BESP1810P2002026-09-24
05407013460237mRNA Buffer 112 : 200L BagBESP1811P200BESP1811P2002026-09-24
05407013460244mRNA Buffer 112 : 1L Bag sampleBESP1811P1SAMBESP1811P1SAM2026-09-24
05407013460251mRNA Buffer 113 : 1L Bag sampleBESP1812P1SAMBESP1812P1SAM2026-09-24
05407013460268mRNA Buffer 113 : 200L BagBESP1812P200BESP1812P2002026-09-24
05407013460275GLS Lonza Medium Base 1 - 10kgBESP904X10BESP904X102026-09-24
05407013460299GLS Feed Base N, 100LBESP908JBESP908J2026-09-24
05407013460015Lonza Medium Base D2 - 100g sampleBESP1021XSAMBESP1021XSAM2026-05-21
05407013460022GLS CHO Feed Base S - 100g sampleBESP1298XSAMBESP1298XSAM2026-05-21
05407013460039dCHO Feed Base P - 100g sampleBESP1022XSAMBESP1022XSAM2026-05-21
05407013460046GLS CHO Feed Base D - 100g sampleBESP797XSAMBESP797XSAM2026-05-21
05407013460053GLS Lonza Medium Base 5 - 100g sampleBESP1462XSAMBESP1462XSAM2026-05-21
05407013460060GLS CHO Feed Base U - 100g sampleBESP1300XSAMBESP1300XSAM2026-05-21
05407013460077GLS Feed Base N - 100g sampleBESP908XSAMBESP908XSAM2026-05-21
05407013460084GLS Lonza Medium Base 4 - 100g sampleBESP1302XSAMBESP1302XSAM2026-05-21
05407013460091TheraPRO® CHO Feed - 100g sampleBESP1603XSAMBESP1603XSAM2026-05-21
05407013460107GLS CHO Vitamin Mix - 100g sampleBESP808XSAMBESP808XSAM2026-05-21
05407013460114TheraPRO® CHO Production Med.-100g samplBESP1571XSAMBESP1571XSAM2026-05-21
05407013460008T-32 1L Sample bagBESP1799P1SAMBESP1799P1SAM2026-04-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05407013460206mRNA Buffer 103 : 1L Bag sampleLonza VerviersPPM2026-09-24
05407013460213mRNA Buffer 103 : 200L BagLonza VerviersPPM2026-09-24
05407013460237mRNA Buffer 112 : 200L BagLonza VerviersPPM2026-09-24
05407013460244mRNA Buffer 112 : 1L Bag sampleLonza VerviersPPM2026-09-24
05407013460251mRNA Buffer 113 : 1L Bag sampleLonza VerviersPPM2026-09-24
05407013460268mRNA Buffer 113 : 200L BagLonza VerviersPPM2026-09-24
04015630967162ISH Peroxidase InhibitorVentana Medical Systems, Inc.PPM2026-07-13
04049016151272FITC-labelled anti-human IgG (primate absorbed)EUROIMMUN Medizinische Labordiagnostika AGPPM2026-06-10
04049016151289Biotin-labelled anti-human IgGEUROIMMUN Medizinische Labordiagnostika AGPPM2026-06-10
04049016151296FITC-labelled Avidin (biotin affine)EUROIMMUN Medizinische Labordiagnostika AGPPM2026-06-10
04049016151630FITC-labelled anti-human IgG (primate absorbed)EUROIMMUN Medizinische Labordiagnostika AGPPM2026-06-10
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00846405023417Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-09
00846405012305Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
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00846405012435Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405012459Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405012466Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405012473Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405012497Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405012503Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405012510Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405012527Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405012534Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405012541Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405012558Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405012565Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08