FDA.reportPublic FDA data

PBW Buffer

Primary DI
00840075404774
Brand
PBW Buffer
Company
Lonza Walkersville, Inc.
Model
08-998E
Published
2026-10-12
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
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
00840075404774PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840075404774008400754047748400754047740840075404774

GMDN Terms#

Term, Definition table
TermDefinition
Cell culture buffered saline solutionA buffered saline solution intended to be used during cell culture for processing e.g., washing, diluting, rinsing, storing, transporting of cells, and/or adjusting osmolality of a cell culture medium. It is not intended for in vitro diagnostic use. This is a single-use device.

Regulatory Flags#

DUNS number
609095955
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
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
00840075404781PBS Buffer08-999E2026-10-12
00840075404798Column Cleaning Buffer08-1000E2026-10-12
008400754048041M NaOH Buffer08-1001E2026-10-12
008400754048111.25% NaCl RBC Washing Buffer08-1002E2026-10-12
008400754048283.8 mM PBW Lysis Buffer08-1003E2026-10-12
00840075404729TheraPEAK X-VIVO™ 15 without Gentamicin or Phenol Red08-997B2026-05-27
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840075404781PBS BufferLonza Walkersville, Inc.KIT2026-10-12
00840075404798Column Cleaning BufferLonza Walkersville, Inc.KIT2026-10-12
008400754048041M NaOH BufferLonza Walkersville, Inc.KIT2026-10-12
008400754048111.25% NaCl RBC Washing BufferLonza Walkersville, Inc.KIT2026-10-12
008400754048283.8 mM PBW Lysis BufferLonza Walkersville, Inc.KIT2026-10-12
05407013460275GLS Lonza Medium Base 1 - 10kgLonza VerviersKIT2026-09-24
05407013460299GLS Feed Base N, 100LLonza VerviersKIT2026-09-24
00840075404729TheraPEAK X-VIVO™ 15 without Gentamicin or Phenol RedLonza Walkersville, Inc.KIT2026-05-27
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
00840075400677HAL-MEM WITH LAH #00-0704-00, 200L bagLonza 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