FDA.reportPublic FDA data

Water for Injection, USP Sterile Grade

Primary DI
B891WFIUSP1XL0
Brand
Water for Injection, USP Sterile Grade
Company
INTERMOUNTAIN LIFE SCIENCES, LLC
Model
03
Catalog number
WFI-USP-1XL
Published
2020-08-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Contact Domains#

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
B891WFIUSP1XL0PrimaryHIBCC0

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

Contacts#

Phone, Email table
PhoneEmail
8012828610info@ilsgmp.com

Regulatory Flags#

DUNS number
117437522
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B891BSSPBS1X66Phosphate Buffered Saline (PBS) 1X w/o Ca & Mg, Sterile Solution04BSS-PBS-1X62020-08-14
B891WCMTSB1XL0Tryptic Soy Broth, Non-Animal Solution03WCM-TSB-1XL2020-08-14
B891WCMTSB20L0Tryptic Soy Broth, Non-Animal Solution04WCM-TSB-20L2020-08-14
B891WCMTSB2XL0Tryptic Soy Broth, Non-Animal Solution04WCM-TSB-2XL2020-08-14
B891WCMTSB50L0Tryptic Soy Broth, Non-Animal Solution03WCM-TSB-50L2020-08-14
B891WFIEPZ20L0Water for Injection, EP/USP Sterile Grade04WFI-EPZ-20L2020-08-14
B891WFIEPZ2XL0Water for Injection, EP/USP Sterile Grade04WFI-EPZ-2XL2020-08-14
B891WFIMGW20L0Molecular Grade Water03WFI-MGW-20L2020-08-14
B891WFIUSP10L0Water for Injection, USP Sterile Grade03WFI-USP-10L2020-08-14
B891WFIUSP1X66Water for Injection, USP Sterile Grade05WFI-USP-1X62020-08-14
B891WFIUSP20L0Water for Injection, USP Sterile Grade04WFI-USP-20L2020-08-14
B891WFIUSP2XL0Water for Injection, USP Sterile Grade04WFI-USP-2XL2020-08-14
B891WFIUSP5XM6Water for Injection, USP Sterile Grade04WFI-USP-5XM2020-08-14
B891WIRUSP1X66Water for Irrigation, USP Sterile Grade05WIR-USP-1X62020-08-14
B891WIRUSP20L0Water for Irrigation, USP Sterile Grade04WIR-USP-20L2020-08-14
B891WIRUSP2XL0Water for Irrigation, USP Sterile Grade03WIR-USP-2XL2020-08-14
B891WIRUSP5XM6Water for Irrigation, USP Sterile Grade03WIR-USP-5XM2020-08-14
B891WPWCMG1X66Cell and Molecular UltraPure Sterile Water03WPW-CMG-1X62020-08-14
B891WPWUSN1X66Purified Water, USP Non-Sterile Grade05WPW-USN-1X62020-08-14
B891WPWUSN20L0Purified Water, USP Non-Sterile Grade04WPW-USN-20L2020-08-14

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Primary DI, Brand, Company table
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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
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