FDA.reportPublic FDA data

iClean

Primary DI
16974488990720
Brand
iClean
Company
Huachenyang (Shenzhen) Technology Co., Ltd
Model
CY-F002-38
Published
2023-10-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

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
16974488990720PrimaryGS10
06974488990723Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1697448899072016974488990720
06974488990723069744889907236974488990723

GMDN Terms#

Term, Definition table
TermDefinition
Cell preservation/storage/dilution solution IVDA solution intended to be used for the preservation, storage, washing, dilution and/or resuspension of cells (e.g., red and/or white blood cells, epithelial, bacterial, fungal, etc.) in a clinical specimen or a cell isolate, to maintain cell stability and/or facilitate further in vitro diagnostic testing.

Regulatory Flags#

DUNS number
548237157
Device count
100
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
16974488991055iCleanCY-960002024-05-30
16974488991062iCleanCY-98000DM2024-05-30
26974488991052iCleanCY-960002024-05-30
26974488991069iCleanCY-98000DM2024-05-30
16974488991048iCleanCY-98000T2024-04-23
26974488991045iCleanCY-98000T2024-04-23
16974488991000iCleanCY-930502024-04-15
16974488991024iCleanCY-960002024-04-15
26974488991007iCleanCY-930502024-04-15
26974488991021iCleanCY-960002024-04-15
16974488990935iCleanCY-90001-FS2024-03-29
16974488990942iCleanCY-F003-40 (NGS)2024-03-29
16974488990959iCleanCY-B-F005-202024-03-29
16974488990966iCleanCY-B-F005-202024-03-29
16974488990973iCleanCY-7422024-03-29
16974488990980iCleanCY-F003-30 (Amies)2024-03-29
16974488990997iCleanCY-F003-30 (Amies)2024-03-29
26974488990932iCleanCY-90001-FS2024-03-29
26974488990949iCleanCY-F003-40 (NGS)2024-03-29
26974488990956iCleanCY-B-F005-202024-03-29

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
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
10190302002813Hanks’ Balanced Salt Solution (HBSS) (1X)LIFE TECHNOLOGIES LIMITEDKIP2023-10-02