AccessGUDID - DEVICE: GluLink (06975640490013)

GUDID

Device Identifier (DI) Information

Brand Name: GluLink
Version or Model: /
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: HeYuan FandDing Medical Co Ltd

Primary DI Number: 06975640490013
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 711353062 *Terms of Use

Device Description: No description.

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:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
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?
64412	Rapid test/self-testing data interpretive/transfer/validation software IVD	A software program intended to be used by a healthcare professional or patient to capture, interpret, transfer, and/or validate the results of data from an in vitro diagnostic rapid test/self-test [e.g., SARS-CoV-2 antigen/antibody self-test, influenza virus immunochromatographic rapid test (ICT), glucose rapid test] using a mobile device (e.g., smartphone, tablet). The results are transmitted to an Internet-based platform or a centralized database for assessment by a healthcare professional and/or for clinical research applications. Data may be reviewed by the patient and clinician, or not made available to the patient.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OUG	Medical Device Data System

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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: ea15c2f2-9374-49de-8715-20565ea3936b
Public Version Date: November 25, 2022
Public Version Number: 1
DI Record Publish Date: November 17, 2022

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
06975640490006	1	06975640490013		In Commercial Distribution

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: Yes
Expiration Date: No
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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