FDA.reportPublic FDA data

Sodium Chloride 0.9% (Normal Saline), USP Sterile Grade

Primary DI
B891Z13766
Brand
Sodium Chloride 0.9% (Normal Saline), USP Sterile Grade
Company
INTERMOUNTAIN LIFE SCIENCES, LLC
Model
04
Catalog number
Z1376
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
KIPFormulations, Balanced Salt Solutions

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KIPFormulations, Balanced Salt SolutionsHematology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B891Z13766PrimaryHIBCC0
B891Z13760Unit 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
6
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06979203760278Chiwell BiotechnologyNingbo Chiwell Biotechnology Co., LtdKIP2026-01-07
05407010128505DPBS 0.0095M(PO4) w/o Ca,Mg-500mL sampleLonza VerviersKIP2025-08-20
05407010127454PBS w/o Ca-Mg 5L JerrycanLonza VerviersKIP2025-06-11
05407010127461PBS w/o Ca-Mg 1L bottleLonza VerviersKIP2025-06-11
05407010127478PBS w/o Ca-Mg Tween 20 0.1% 5L jerrycanLonza VerviersKIP2025-06-11
05407010127485Physiologic Water Tween20 0.05% 5LjerrycLonza VerviersKIP2025-06-11
05407010127492DPBS 1X with 1M NaCl - 10 L BagLonza VerviersKIP2025-06-11
05407010127508DPBS 1X - 20 L Bag Lonza VerviersKIP2025-06-11
05407010127515DPBS 1X with 0.06M NaCl - 20L bagLonza VerviersKIP2025-06-11
05407010127522DPBS 1X with 0.4M NaCl - 20L bagLonza VerviersKIP2025-06-11
05407010127539DPBS 1X with 0.08M NaCl - 10 L bagLonza VerviersKIP2025-06-11
05407010127546IBEX PBS : 1000L BagLonza VerviersKIP2025-06-11
05407010127553IBEX PBS : 1L Bag SAMPLELonza VerviersKIP2025-06-11
05407010127560DPBS IC51 1L bagLonza VerviersKIP2025-06-11
05407010127577DPBS IC51 20LLonza VerviersKIP2025-06-11
05407010127133DPBS 0.0095M(PO4) w/o Ca,Mg,500mlINTERNELonza VerviersKIP2025-05-26
05407010127140DPBS 0.0095M(PO4) w/o Ca, Mg, 1L INTERNELonza VerviersKIP2025-05-26
05407010126938DPBS 0.0095M(PO4) w/o Ca,Mg-250ml sample Lonza VerviersKIP2025-05-14
05407010126174NCTF Powder - 5LLonza VerviersKIP2025-03-20
05407010125726NCTF Powder - 380gLonza VerviersKIP2025-01-08
16974488990713iCleanHuachenyang (Shenzhen) Technology Co., LtdKIP2023-10-24
16974488990720iCleanHuachenyang (Shenzhen) Technology Co., LtdKIP2023-10-24
06974488990716iCleanHuachenyang (Shenzhen) Technology Co., LtdKIP2023-10-24
06974488990723iCleanHuachenyang (Shenzhen) Technology Co., LtdKIP2023-10-24
10190302001069Phosphate-Buffered Saline (PBS) (1X), pH 7.4LIFE TECHNOLOGIES LIMITEDKIP2023-10-02
10190302002660Hanks’ Balanced Salt Solution (HBSS) (1X)LIFE TECHNOLOGIES LIMITEDKIP2023-10-02
10190302002707Dulbecco’s Phosphate Buffered Saline (D-PBS) (1X)LIFE TECHNOLOGIES LIMITEDKIP2023-10-02
10190302002714Dulbecco’s Phosphate Buffered Saline (D-PBS) (1X)LIFE TECHNOLOGIES LIMITEDKIP2023-10-02
10190302002752Hanks’ Balanced Salt Solution (HBSS) (10X)LIFE TECHNOLOGIES LIMITEDKIP2023-10-02
10190302002776Dulbecco’s Phosphate Buffered Saline (D-PBS) (10X)LIFE TECHNOLOGIES LIMITEDKIP2023-10-02