AccessGUDID - DEVICE: Atellica IM Tup (00630414600253)

GUDID

Device Identifier (DI) Information

Brand Name: Atellica IM Tup
Version or Model: 10995712
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 10995712
Company Name: Siemens Healthcare Diagnostics Inc.

Primary DI Number: 00630414600253
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 064608573 *Terms of Use

Device Description: T Uptake (Tup) Atellica IM - RGT 50T

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?
54397	Multiple thyroid hormone uptake (T-uptake) IVD, kit, chemiluminescent immunoassay	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of the unbound/free portion of multiple proteins [e.g., thyroxine binding globulin (TBG), transthyretin and/or albumin] associated with thyroid hormone uptake, in a clinical specimen, using a chemiluminescent immunoassay method. It is typically used to aid in the assessment of thyroid hormone binding capacity for the diagnosis of thyroid disorders associated with hypothyroidism or hyperthyroidism.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KHQ	RADIOASSAY, TRIIODOTHYRONINE UPTAKE

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K970539	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
Special Storage Condition, Specify: Store Upright, Protect from Light, Do not freeze, Resuspend.
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: 8481bf54-b06c-4876-ac89-139b1f634b60
Public Version Date: February 05, 2024
Public Version Number: 6
DI Record Publish Date: February 06, 2018