FDA.reportPublic FDA data

HAL-MEM WITH LAH #00-0704-00, 200L bag

Primary DI
00840075400677
Brand
HAL-MEM WITH LAH #00-0704-00, 200L bag
Company
Lonza Walkersville, Inc.
Model
08-296E
Catalog number
08-296E
Published
2022-12-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true

Product Codes#

Code, Name table
CodeName
KITMedia And Components, Synthetic Cell And Tissue Culture

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KITMedia And Components, Synthetic Cell And Tissue CultureHematology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840075400677PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840075400677008400754006778400754006770840075400677

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.

Regulatory Flags#

DUNS number
609095955
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840075404705CHO Feed Base AWVSP794X202026-05-13
00840075404712CHO Feed Base AWVSP794XSAM2026-05-13
00840075404682CHO Feed Base BWVSP795X202026-03-05
00840075404699CHO Feed Base BWVSP795XSAM2026-03-05
00840075404651CHO Feed Base FWVSP799D2026-02-26
00840075404668CHO Feed Base FWVSP799X202026-02-26
00840075404675CHO Feed Base FWVSP799XSAM2026-02-26
00840075404644X-VIVO 15 without Phenol Red and Gentamicin contains Recombinant TransferrinWVSP1457P1SAMWVSP1457P1SAM2026-02-09
00840075404583GLS CHO Feed FWVSP799B0.5WVSP799B0.52025-12-03
00840075404590GLS CHO Feed FWVSP799B1WVSP799B12025-12-03
00840075404606GLS CHO Feed FWVSP799DWVSP799D2025-12-03
00840075404613GLS CHO Feed FWVSP799JWVSP799J2025-12-03
00840075404620GLS CHO Feed FWVSP799X20WVSP799X202025-12-03
00840075404637GLS CHO Feed FWVSP799XSAMWVSP799XSAM2025-12-03
00840075404545TheraPRO® CHO FeedWVSP1603B1XWVSP1603B1X2025-10-14
00840075404552TheraPRO® CHO FeedWVSP1603BXWVSP1603BX2025-10-14
00840075404569TheraPRO® CHO FeedWVSP1603DXWVSP1603DX2025-10-14
00840075404576TheraPRO® CHO FeedWVSP1603JXWVSP1603JX2025-10-14
00840075404521CHO Feed Base LWVSP906XSAMWVSP906XSAM2025-09-12
00840075404538TheraPRO CHO Expansion MediumWVSP1630QWVSP1630Q2025-09-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10190302001236Minimum Essential Medium (MEM) (1X)LIFE TECHNOLOGIES LIMITEDKIT2023-10-02
10190302003650Dulbeccos Modified Eagle MediumLIFE TECHNOLOGIES LIMITEDKIT2023-10-02
10190302004459BME, Basal Medium (Eagle) (1X)LIFE TECHNOLOGIES LIMITEDKIT2023-10-02
10190302004718Minimum Essential Medium (MEM) (1X)LIFE TECHNOLOGIES LIMITEDKIT2023-10-02
00840075400141X-VIVO 10 w/o Gent,PR&w/ RecTrnsfrn 50LLonza Walkersville, Inc.KIT2022-12-08
00840075400202STD ProCHO 5 Powder, 500 LLonza Walkersville, Inc.KIT2022-12-08
00840075400233RoosterBasal(TM)-MSC-CC, 500mlLonza Walkersville, Inc.KIT2022-12-08
00840075400264Insect-XPRESS w/ L-Gln 1 LLonza Walkersville, Inc.KIT2022-12-08
00840075400301TheraPEAK™ SfAAV™ 1L bottleLonza Walkersville, Inc.KIT2022-12-08
00840075400349VEGGIE 10 MEDIUM WITH ADDITIVES, 200LLonza Walkersville, Inc.KIT2022-12-08
00840075400356TheraPEAK™ X-VIVO™ 15 w/o Gent or PR, 1LLonza Walkersville, Inc.KIT2022-12-08
00840075400363Solution E LifeCell p/n 131P0063, lL botLonza Walkersville, Inc.KIT2022-12-08
00840075400370TheraPEAK™ Lymphocyte Separation MediumLonza Walkersville, Inc.KIT2022-12-08
00840075400493UltraCULTURE, 200L bagLonza Walkersville, Inc.KIT2022-12-08
00840075400653TheraPEAK™ X-VIVO™ 15 w/o Gent or PR, 5LLonza Walkersville, Inc.KIT2022-12-08
00840075400936Solution E LifeCell 131P0077-02, 100L drLonza Walkersville, Inc.KIT2022-12-08
00840075400981RPMI1640 4.5g/L GLUC,NAHCO3,W/O GLUT,50LLonza Walkersville, Inc.KIT2022-12-08
00840075400998TheraPEAK ACK Lysing Buffer (1x), 100mLLonza Walkersville, Inc.KIT2022-12-08
00840075401049RPMI 1640 W/GLUT. & GENTAM., 500 ml botLonza Walkersville, Inc.KIT2022-12-08
00840075401100Dulbecco's (PBS) w/o Ca and Mg, lL botLonza Walkersville, Inc.KIT2022-12-08
00840075401179SOLUTION Z LIFECELL P/N 131P0120, 75LLonza Walkersville, Inc.KIT2022-12-08
008400754012234Cell Insect CD Medium, 1LLonza Walkersville, Inc.KIT2022-12-08
00840075401292STD PowerCHO Advance 100 LLonza Walkersville, Inc.KIT2022-12-08
00840075401414ProCHO 5 serum-free media 1 LLonza Walkersville, Inc.KIT2022-12-08
00840075401476STD PowerCHO Advance 10LLonza Walkersville, Inc.KIT2022-12-08
00840075401483Solution Z LifeCell P/N 131P0115, 1LLonza Walkersville, Inc.KIT2022-12-08
00840075401544STD PowerCHO-2w/oPEG,InsProlpCit2777.8gLonza Walkersville, Inc.KIT2022-12-08
00840075401629ProCHO 4 w/o Phenol Red, 1 LLonza Walkersville, Inc.KIT2022-12-08
00840075401643Veggie 10 Medium with Additives-20L bagLonza Walkersville, Inc.KIT2022-12-08
00840075401704Pro293S-CDM, for suspension cells, 1 LLonza Walkersville, Inc.KIT2022-12-08