FDA.reportPublic FDA data

TheraPEAK® T-VIVO® MEDIUM 5L BAG

Primary DI
05407010126969
Brand
TheraPEAK® T-VIVO® MEDIUM 5L BAG
Company
Lonza Verviers
Model
BP08-970H
Catalog number
BP08-970H
Published
2025-05-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
JCFLymphocyte Separation Medium

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JCFLymphocyte Separation MediumHematology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05407010126969PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05407010126969054070101269695407010126969

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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 VerviersJCF2022-09-12
05407010122572X-Vivo10 w/o Gent, PR w/ Rec Transf, 10LLonza VerviersJCF2022-09-12
05407010122589X-VIVO 15 w/o Gentamycin and PR - 3L bagLonza VerviersJCF2022-09-12
05407010122756X-VIVO 15 w/o PR and Gentamicine 10L bagLonza VerviersJCF2022-09-12
05407010122817TheraPEAK™ X-VIVO™ 15 w REC TRANSF 1LLonza VerviersJCF2022-09-12
05407010122824TheraPEAK X-VIVO10(04-743) contains rec transf -1LLonza VerviersJCF2022-09-12
05407010122831X-VIVO 10 w/o Gentamycin w/o PR, 1LLonza VerviersJCF2022-09-12
05407010122848TheraPEAK™ X-VIVO™ 15 w/o Gent or PR, 1LLonza VerviersJCF2022-09-12