AccessGUDID - DEVICE: iClean (26974488990079)

GUDID

Device Identifier (DI) Information

Brand Name: iClean
Version or Model: CY-F005-20
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Huachenyang (Shenzhen) Technology Co., Ltd

Primary DI Number: 26974488990079
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 100
Labeler D-U-N-S® Number*: 548237157 *Terms of Use

Device Description: The product consists of a tube with viral transport medium and one piece of sterile sampling swab.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
62773	General specimen collection kit IVD, clinical	A 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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JSM	Culture Media, Non-Propagating Transport

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K212856	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: bd27a6b4-a045-47bf-a254-035963fd2f60
Public Version Date: November 15, 2022
Public Version Number: 1
DI Record Publish Date: November 07, 2022