FDA.reportPublic FDA data

AA-5: 0.4 M Acetic Acid -200L Bag

Primary DI
05407010125313
Brand
AA-5: 0.4 M Acetic Acid -200L Bag
Company
Lonza Verviers
Model
BESP1750P200
Catalog number
BESP1750P200
Published
2024-08-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true

Product Codes#

Code, Name table
CodeName
KITMedia And Components, Synthetic Cell And Tissue Culture
PPMGeneral Purpose Reagent

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KITMedia And Components, Synthetic Cell And Tissue CultureHematology1
PPMGeneral Purpose ReagentPathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05407010125313PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05407010125313054070101253135407010125313

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
370158847
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
05407010128222Bulk Packaged ster. filtered WFI - 500mlBESP1064P0.5BESP1064P0.52026-03-30
054070101286350.1 M NaCl Module L : 1L Bag SAMPLEBESP1647P1SAMBESP1647P1SAM2026-03-30
05407010128192PowerCHO Advance Powder - 5LVPW-1027BVPW-1027B2026-03-26
05407010129861T-32 1000L bagBESP1799P1000BESP1799P10002026-03-26
05407010129878T-32 200L bagBESP1799P200BESP1799P2002026-03-26
05407010129885NaAc-35 - 1000L bagBESP1800P1000BESP1800P10002026-03-26
05407010129892NaAc-35 - 200L BagBESP1800P200BESP1800P2002026-03-26
05407010129908NaAc-35 -1L Sample bagBESP1800P1SAMBESP1800P1SAM2026-03-26

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