AccessGUDID - DEVICE: Atellica IM TSH3-Ultra II (00630414624525)

GUDID

Device Identifier (DI) Information

Brand Name: Atellica IM TSH3-Ultra II
Version or Model: 11208707
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 11208707
Company Name: Siemens Healthcare Diagnostics Inc.

Primary DI Number: 00630414624525
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 064608573 *Terms of Use

Device Description: TSH3-ULII Atellica IM – RGT 550T

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?
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 [?]
K233050	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
Handling Environment Temperature: between 2 and 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 2cb9ffd0-848d-44da-b93c-b0ef022f9c11
Public Version Date: April 03, 2025
Public Version Number: 2
DI Record Publish Date: May 22, 2024