AccessGUDID - DEVICE: MAGLUMI 2000 TSH (06947145500023)

GUDID

Device Identifier (DI) Information

Brand Name: MAGLUMI 2000 TSH
Version or Model: 130603013M
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 130603013M
Company Name: Shenzhen New Industries Biomedical Engineering Co., Ltd.

Primary DI Number: 06947145500023
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 421745241 *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:	Yes
Prescription Use (Rx):	Yes
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?
54386	Thyroid stimulating hormone (TSH) IVD, kit, chemiluminescent immunoassay	A collection of reagents and other associated materials intended to be used for the quantitative measurement of thyroid stimulating hormone (TSH) in a clinical specimen, using a chemiluminescent immunoassay method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JLW	Radioimmunoassay, Thyroid-Stimulating Hormone

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K162698	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
Storage Environment Temperature: between 2 and 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 47d84b52-a29f-4721-a066-ed3e55cee5d0
Public Version Date: August 10, 2022
Public Version Number: 1
DI Record Publish Date: August 02, 2022