iClean

Primary DI
26974488990383
Brand
iClean
Company
Huachenyang (Shenzhen) Technology Co., Ltd
Model
CY-98000A
Published
2022-12-06
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
26974488990383PackageGS1200In Commercial Distribution
16974488990386PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2697448899038326974488990383
1697448899038616974488990386

GMDN Terms#

Term, Definition table
TermDefinition
Oral/upper respiratory tract specimen collection kit IVD, home-useA collection of devices intended to be used by a layperson in the home to self-collect and mail a saliva/oral, nasal, nasopharyngeal, and/or oropharyngeal specimen to a clinical laboratory for in vitro diagnostic investigation (e.g., COVID-19 testing); it may in addition be used in a clinical setting by a healthcare professional. It consists of a non-suctioning specimen sampling/collection tool(s) [e.g., swab, brush, saliva collection mouthpiece/funnel], a covered specimen receptacle with or without an additive/medium [e.g., preservative solution, microbiological medium (e.g., Amies, Stuart, viral transport/inactivation medium)], and mailing packing/envelope. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
548237157
Device count
1
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