FDA.reportPublic FDA data

X-Vivo15(04-744)contains rec tran 1L bag

Primary DI
05407010122626
Brand
X-Vivo15(04-744)contains rec tran 1L bag
Company
Lonza Verviers
Model
BEBP02-054P1
Published
2022-09-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
JCFLymphocyte Separation Medium
NDSMedia, Culture, Ex Vivo, Tissue And Cell

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JCFLymphocyte Separation MediumHematology1
NDSMedia, Culture, Ex Vivo, Tissue And CellGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05407010122626PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05407010122626054070101226265407010122626

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
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
05407013460282Bulk Packaged ster. filtered WFI - 1LBESP1325P1SAMBESP1325P1SAM2026-09-24
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05407010126969TheraPEAK® T-VIVO® MEDIUM 5L BAGLonza VerviersJCF2025-05-14
05407010125818X-VIVO 10 with Gent and Phenol Red, 1LLonza VerviersJCF2025-02-10
00628451099017Lympholyte-HCedarlane CorporationJCF2024-12-10
00628451099024Lympholyte-HCedarlane CorporationJCF2024-12-10
00628451099048Lympholyte-HCedarlane CorporationJCF2024-12-10
00628451099482Lympholyte-HCedarlane CorporationJCF2024-12-10
00628451099499Lympholyte-HCedarlane CorporationJCF2024-12-10
05051716000544Leucosep TubesOxford Immunotec, Inc.JCF2023-03-31
05051716000087Leucosep TubesOxford Immunotec, Inc.JCF2023-02-07
05407010124279X-Vivo10 w/o Gent, PR w/ Rec Transf, 1LLonza VerviersJCF2022-12-09
05407010124330X-VIVO 15 w/o PR and Gentamicine 1L bagLonza VerviersJCF2022-12-09
05407010124347X-VIVO 15 w/o PR and Gentamicine 1L bag sampleLonza VerviersJCF2022-12-09
06284510990011Lympholyte-HCedarlane CorporationJCF2022-12-08
06284510990028Lympholyte-HCedarlane CorporationJCF2022-12-08
06284510990042Lympholyte-HCedarlane CorporationJCF2022-12-08
06284510990486Lympholyte-HCedarlane CorporationJCF2022-12-08
06284510990493Lympholyte-HCedarlane CorporationJCF2022-12-08
07540207854158SepMate-15Stemcell Technologies Canada IncJCF2022-10-21
07540207854509SepMate-50Stemcell Technologies Canada IncJCF2022-10-21
17540207854155SepMate-15Stemcell Technologies Canada IncJCF2022-10-21
17540207854506SepMate-50Stemcell Technologies Canada IncJCF2022-10-21
07540207854165SepMate-15Stemcell Technologies Canada IncJCF2022-10-21
07540207854516SepMate-50Stemcell Technologies Canada IncJCF2022-10-21
05407010122565STD X-Vivo 15 w/o gentamicin and pr, 1LLonza VerviersNDS2022-09-12
05407010122565STD X-Vivo 15 w/o gentamicin and pr, 1LLonza VerviersJCF2022-09-12
05407010122572X-Vivo10 w/o Gent, PR w/ Rec Transf, 10LLonza VerviersNDS2022-09-12
05407010122572X-Vivo10 w/o Gent, PR w/ Rec Transf, 10LLonza VerviersJCF2022-09-12
05407010122589X-VIVO 15 w/o Gentamycin and PR - 3L bagLonza VerviersNDS2022-09-12
05407010122589X-VIVO 15 w/o Gentamycin and PR - 3L bagLonza VerviersJCF2022-09-12
05407010122756X-VIVO 15 w/o PR and Gentamicine 10L bagLonza VerviersJCF2022-09-12