iClean

GUDID 26974488990338

Huachenyang (Shenzhen) Technology Co., Ltd

Cell preservation/storage/dilution solution IVD

• Primary Device ID: 26974488990338
• NIH Device Record Key: e72d7a22-031d-4a74-bffa-86835c9ce064
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: iClean
• Version Model Number: CY-F002-35
• Company DUNS: 548237157
• Company Name: Huachenyang (Shenzhen) Technology Co., Ltd
• Device Count: 100
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06974488990334 [Unit of Use]
GS1	16974488990331 [Primary]
GS1	26974488990338 [Package]; Contains: 16974488990331; Package: carton [10 Units]; In Commercial Distribution

FDA Product Code

• KIP: Formulations, Balanced Salt Solutions

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-12-14
• Device Publish Date: 2022-12-06

On-Brand Devices [iClean]

• 36974488990014: CY-93050RT
• 36974488990021: CY-93050R-TS
• 26974488990055: CY-98000PS-P2
• 36974488990076: The product consists of a tube with viral transport medium and one piece of sterile sampling swa
• 16974488990041: The product consists of a tube with viral transport medium, one piece of sterile sampling swab a
• 36974488990069: The breaking point is 90mm.
• 26974488990093: The breaking point is 80mm.
• 26974488990154: The product consists of a swab (CY-93050F-90) and a 10mL tube with 3 mL liquid and a biobag.
• 26974488990130: CY-98000T
• 26974488990123: CY-90003T
• 26974488990116: CY-742-70
• 26974488990109: CY-90001-FS
• 26974488990444: Inactivated transport medium
• 06974488990433: CY-98000PS
• 06974488990402: CY-90001FS-80
• 06974488990396: CY-90001BF-80
• 26974488990383: CY-98000A
• 26974488990376: CY-98000-P2
• 26974488990369: CY-98000-P2
• 26974488990352: CY-98000-P1
• 26974488990345: CY-90001
• 26974488990338: CY-F002-35
• 26974488990314: CY-F005-20
• 26974488990307: CY-F005-20
• 26974488990284: CY-F005-20
• 26974488990277: CY-F005-20
• 26974488990260: CY-F005-20
• 26974488990253: CY-98000
• 06974488990235: CY-93050
• 26974488990208: The product consists of a tube with viral transport medium and two model sampling swab (CY-93050
• 26974488990192: The product consists of a tube with viral transport medium and one piece of sterile sampling swa
• 26974488990185: Non-inactivated transport medium
• 26974488990178: CY-93050R-TS
• 26974488990161: CY-93050R-TS
• 06974488990648: CY-90001F-81
• 26974488990628: CY-F003-30
• 16974488990614: CY-F005-20
• 26974488990543: CY-98000PS
• 26974488990536: CY-93050
• 26974488990529: CY-98000
• 26974488990512: CY-96000
• 26974488990505: CY-95000
• 26974488990482: CY-93050S
• 06974488990723: CY-F002-38
• 06974488990716: CY-F002-38
• 26974488990703: CY-93052
• 26974488990420: CY-96000
• 26974488990772: CY-93050R-TS
• 26974488990741: CY-M002-96A
• 26974488990734: CY-90001F-81