FDA.reportPublic FDA data

iClean

Primary DI
06974488990716
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
Rx
false
OTC
false
Sterile
false
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
16974488990713PrimaryGS10
06974488990716Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1697448899071316974488990713
06974488990716069744889907166974488990716

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
548237157
Device count
100
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
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
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
16974488990720iCleanHuachenyang (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