FDA.report

X-VIVO 15 w/o PR and Gentamicine 10L bag

Primary DI
05407010122756
Brand
X-VIVO 15 w/o PR and Gentamicine 10L bag
Company
Lonza Verviers
Model
BESP1457P10
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

Related Records

Product Codes

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

Product Code Classifications

CodeDeviceSpecialtyClass
JCFLymphocyte Separation MediumHematology1
NDSMedia, Culture, Ex Vivo, Tissue And CellGastroenterology, Urology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05407010122756PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05407010122756054070101227565407010122756

GMDN Terms

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

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 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

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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
05407010122817TheraPEAK™ X-VIVO™ 15 w REC TRANSF 1LLonza VerviersNDS2022-09-12
05407010122817TheraPEAK™ X-VIVO™ 15 w REC TRANSF 1LLonza VerviersJCF2022-09-12
05407010122824TheraPEAK X-VIVO10(04-743) contains rec transf -1LLonza VerviersNDS2022-09-12
05407010122824TheraPEAK X-VIVO10(04-743) contains 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