FDA.report

TheraPEAK™ MSCBM™ - 1 L

Primary DI
05407010120530
Brand
TheraPEAK™ MSCBM™ - 1 L
Company
Lonza Verviers
Model
BEBP12-934Q
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
KITMedia And Components, Synthetic Cell And Tissue Culture

Product Code Classifications

CodeDeviceSpecialtyClass
KITMedia And Components, Synthetic Cell And Tissue CultureHematology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05407010120530PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05407010120530054070101205305407010120530

GMDN Terms

TermDefinition
Cell culture medium IVDA liquid based tissue culture medium containing essential nutrients, sugars, amino acids and growth factors, intended to be used for the in-vitro maintenance, sustenance, and cultivation of human cells from a clinical specimen for diagnostic purposes.

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

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00840075404682CHO Feed Base BLonza Walkersville, Inc.KIT2026-03-05
00840075404699CHO Feed Base BLonza Walkersville, Inc.KIT2026-03-05
00840075404651CHO Feed Base FLonza Walkersville, Inc.KIT2026-02-26
00840075404668CHO Feed Base FLonza Walkersville, Inc.KIT2026-02-26
00840075404675CHO Feed Base FLonza Walkersville, Inc.KIT2026-02-26
00840075404644X-VIVO 15 without Phenol Red and Gentamicin contains Recombinant TransferrinLonza Walkersville, Inc.KIT2026-02-09
05407010129823Custom M199 w/o PR w/U1, Pluronic-4L bagLonza VerviersKIT2025-12-23
05407010129830Custom M199 w/o PR w/U1, Pluronic-1L BotLonza VerviersKIT2025-12-23
05407010129694PBS - 1L Bag- SampleLonza VerviersKIT2025-12-16
05407010129687PBS - 1L- SampleLonza VerviersKIT2025-12-15
00840075404583GLS CHO Feed FLonza Walkersville, Inc.KIT2025-12-03
00840075404590GLS CHO Feed FLonza Walkersville, Inc.KIT2025-12-03
00840075404606GLS CHO Feed FLonza Walkersville, Inc.KIT2025-12-03
00840075404613GLS CHO Feed FLonza Walkersville, Inc.KIT2025-12-03
00840075404620GLS CHO Feed FLonza Walkersville, Inc.KIT2025-12-03
00840075404637GLS CHO Feed FLonza Walkersville, Inc.KIT2025-12-03
05407010129656CD CHO Medium AGT-200Lbag filled to 100LLonza VerviersKIT2025-11-13
05407010128994DMEM Glutamax 2% SRPT - 500ml bag SAMPLE Lonza VerviersKIT2025-09-29
05407010128659 ProCHO5 w/Pluro w/o L-Gln or HT 0.5LLonza VerviersKIT2025-09-15
05407010128789ProDoma 3 (KF10) w/o L-Glutamine 20L baLonza VerviersKIT2025-09-15
00840075404521CHO Feed Base LLonza Walkersville, Inc.KIT2025-09-12
00840075404538TheraPRO CHO Expansion MediumLonza Walkersville, Inc.KIT2025-09-12
05407010128499ModProCHO5 w/8mM L-Gln,0.25% Pluro 500mLLonza VerviersKIT2025-08-20
05407010128536CD CHO Medium AGT - 20L bagLonza VerviersKIT2025-08-20
05407010128543CD CHO Medium AGT - 100L Flexsafe bagLonza VerviersKIT2025-08-20
05407010128550CD CHO Medium AGT - 1L bottleLonza VerviersKIT2025-08-20
05407010128567DMEM Glutamax 2% SRPT - 50L bagLonza VerviersKIT2025-08-20
05407010128574DMEM Glutamax 2% SRPT - 1L bottleLonza VerviersKIT2025-08-20
05407010128581Sky FM03 - 1L bottleLonza VerviersKIT2025-08-20
05407010128598X-Vivo 20 w/o Genta, PR w/ U1,OptiferrinLonza VerviersKIT2025-08-20