FDA.reportPublic FDA data

Water for Irrigation, USP Sterile Grade

Primary DI
B891Z03044
Brand
Water for Irrigation, USP Sterile Grade
Company
INTERMOUNTAIN LIFE SCIENCES, LLC
Model
03
Catalog number
Z0304
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
B891Z03044PrimaryHIBCC0
B891Z03040Unit of UseHIBCC0

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
4
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
B891WFIUSP1XL0Water for Injection, USP Sterile Grade03WFI-USP-1XL2020-08-14
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

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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