iClean

Primary DI
26974488990963
Brand
iClean
Company
Huachenyang (Shenzhen) Technology Co., Ltd
Model
CY-B-F005-20
Published
2024-03-29
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
26974488990963PackageGS18In Commercial Distribution
16974488990966PrimaryGS10
06974488990969Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
2697448899096326974488990963
1697448899096616974488990966
06974488990969069744889909696974488990969

GMDN Terms#

Term, Definition table
TermDefinition
General specimen collection kit IVD, clinicalA collection of in vitro diagnostic devices intended exclusively for professional use for the collection, and preservation and/or transport, of more than one type of clinical specimen (e.g., urine, faeces, sputum, mucous, vaginal secretions) derived from different body regions for in vitro diagnostic investigation [e.g., nucleic acid technique (NAT), histopathology]. The kit consists of a specimen sampling/collection tool(s) [e.g., swab, brush, spatula], and a covered specimen receptacle with or without an additive/medium (e.g., preservation solution, microbiological medium). This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
548237157
Device count
100
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
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