FDA.reportPublic FDA data

Phosphate-Buffered Saline (PBS) (1X), pH 7.4

Primary DI
30190302001063
Brand
Phosphate-Buffered Saline (PBS) (1X), pH 7.4
Company
LIFE TECHNOLOGIES LIMITED
Model
10010015
Published
2023-10-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
false

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
30190302001063PackageGS110In Commercial Distribution
10190302001069PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3019030200106330190302001063
1019030200106910190302001069

GMDN Terms#

Term, Definition table
TermDefinition
Cell culture medium IVDA liquid based tissue culture medium containing essential nutrients, sugars, amino acids and growth factors, intended to be used for the in-vitro maintenance, sustenance, and cultivation of human cells from a clinical specimen for diagnostic purposes.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
229044524
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
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
10190302002912Dulbecco's Phosphate Buffered Saline (D-PBS)141900942016-08-01
10190302002714Dulbecco’s Phosphate Buffered Saline (D-PBS) (1X)140400912023-10-02
10190302002660Hanks’ Balanced Salt Solution (HBSS) (1X)140250502023-10-02
10190302002707Dulbecco’s Phosphate Buffered Saline (D-PBS) (1X)140400832023-10-02
10190302002929Dulbecco's Phosphate Buffered Saline (D-PBS) (1X)141900862023-10-02
10190302001236Minimum Essential Medium (MEM) (1X)103700472023-10-02
10190302002851Hanks’ Balanced Salt Solution (HBSS) (1X)141750532023-10-02
10190302003650Dulbeccos Modified Eagle Medium219690352023-10-02
10190302001069Phosphate-Buffered Saline (PBS) (1X), pH 7.4100100152023-10-02
10190302003001Dulbecco's Phosphate Buffered Saline (D-PBS) (10X)142000592023-10-02
10190302003339Phosphate-Buffered Saline (PBS) (1X), pH 7.2200120192023-10-02
10190302003865Hanks’ Balanced Salt Solution (HBSS) (1X)240200912023-10-02
10190302003872Hanks’ Balanced Salt Solution (HBSS) (1X)240200832023-10-02
10190302004718Minimum Essential Medium (MEM) (1X)512000462023-10-02
10190302002998Dulbecco's Phosphate Buffered Saline (D-PBS) (10X)142000672023-10-02
10190302004220RPMI 1640 (1X) w/o L-Glutamine318700252023-09-27
10190302002868HBSS, w/o CA, MG and PH Red (1X)(CE)141750462019-09-03
10190302002882Hanks' Balanced Salt Solution (HBSS)141800462016-08-01
10190302002813Hanks’ Balanced Salt Solution (HBSS) (1X)141700882023-10-02
10190302002820Hanks’ Balanced Salt Solution (HBSS) (1X)141700702023-10-02

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