FDA.reportPublic FDA data

TheraPEAK X-VIVO10(04-743) contains rec transf -1L

Primary DI
05407010122824
Brand
TheraPEAK X-VIVO10(04-743) contains rec transf -1L
Company
Lonza Verviers
Model
BEP02-055Q
Published
2022-09-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

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
05407010122824PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05407010122824054070101228245407010122824

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
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
05407010129847Buffer C_SUO-001_Module L : 1000L BagBESP1797P1000BESP1797P10002026-02-05
05407010129854Buffer C_SUO-001_Module L : 1L Bag SampBESP1797P1SAMBESP1797P1SAM2026-02-05
05407010129700AA-5: 0.4 M Acetic Acid -500L BagBESP1750P500BESP1750P5002025-12-23
05407010129717Buffer C EZ-001 Module L : 1L Bag SAMPLEBESP1639P1SAMBESP1639P1SAM2025-12-23
05407010129724Buffer D EZ-001 Module L : 1L Bag SAMPLEBESP1640P1SAMBESP1640P1SAM2025-12-23
05407010129731Buffer E1 EZ-001 Module L : 1L BagBESP1641P1BESP1641P12025-12-23
05407010129748Buffer E1 EZ-001 Module L: 1L Bag SAMPLEBESP1641P1SAMBESP1641P1SAM2025-12-23
05407010129755Buffer G EZ-001 Module L : 1L Bag SAMPLEBESP1642P1SAMBESP1642P1SAM2025-12-23
05407010129762Buffer H EZ-001 Module L : 1L Bag SAMPLEBESP1643P1SAMBESP1643P1SAM2025-12-23
05407010129779Buffer I EZ-001 Module L : 1L BagBESP1644P1BESP1644P12025-12-23
05407010129786Buffer I EZ-001 Module L : 1L Bag SAMPLEBESP1644P1SAMBESP1644P1SAM2025-12-23
054070101297932 M NaCl Module L : 1L Bag SAMPLEBESP1645P1SAMBESP1645P1SAM2025-12-23
05407010129809Buffer X1 EZ-001 Module L - 1L BagBESP1648P1BESP1648P12025-12-23
05407010129816Buffer X1 EZ-001 Module L: 1L Bag SAMPLEBESP1648P1SAMBESP1648P1SAM2025-12-23
05407010129823Custom M199 w/o PR w/U1, Pluronic-4L bagBESP1674P5-4BESP1674P5-42025-12-23
05407010129830Custom M199 w/o PR w/U1, Pluronic-1L BotBESP1674Q-4BESP1674Q-42025-12-23
05407010129694PBS - 1L Bag- SampleBESP755P1SAMBESP755P1SAM2025-12-16
05407010129663Buffer_H _T33_SUO-001 Module L : 1000LBESP1798P1000BESP1798P10002025-12-15
05407010129670Buffer_H _T33_SUO-001 Module L : 1L BAGBESP1798P1SAMBESP1798P1SAM2025-12-15
05407010129687PBS - 1L- SampleBESP755QSAMBESP755QSAM2025-12-15

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
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
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 VerviersJCF2022-09-12
05407010122572X-Vivo10 w/o Gent, PR w/ Rec Transf, 10LLonza VerviersNDS2022-09-12
05407010122589X-VIVO 15 w/o Gentamycin and PR - 3L bagLonza VerviersJCF2022-09-12
05407010122589X-VIVO 15 w/o Gentamycin and PR - 3L bagLonza VerviersNDS2022-09-12
05407010122756X-VIVO 15 w/o PR and Gentamicine 10L bagLonza VerviersNDS2022-09-12
05407010122756X-VIVO 15 w/o PR and Gentamicine 10L bagLonza VerviersJCF2022-09-12
05407010122817TheraPEAK™ X-VIVO™ 15 w REC TRANSF 1LLonza VerviersNDS2022-09-12
05407010122817TheraPEAK™ X-VIVO™ 15 w REC TRANSF 1LLonza VerviersJCF2022-09-12
05407010122831X-VIVO 10 w/o Gentamycin w/o PR, 1LLonza VerviersNDS2022-09-12
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
05407010122848TheraPEAK™ X-VIVO™ 15 w/o Gent or PR, 1LLonza VerviersNDS2022-09-12