AccessGUDID - DEVICE: Atellica IM VitD (00630414293837)

GUDID

Device Identifier (DI) Information

Brand Name: Atellica IM VitD
Version or Model: 11206265
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 11206265
Company Name: Siemens Healthcare Diagnostics Inc.

Primary DI Number: 00630414293837
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 064608573 *Terms of Use

Device Description: Vitamin D total 25(OH) (VitD) - Atellica IM - RGT 500T

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?
60922	Multiple form 25-hydroxy vitamin D IVD, kit, chemiluminescent immunoassay	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of multiple forms of 25-hydroxy vitamin D in a clinical specimen, using a chemiluminescent immunoassay.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JIS	Calibrator, primary
MRG	SYSTEM, TEST, VITAMIN D

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K133156	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
Special Storage Condition, Specify: Store upright, Protect from light

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 12c8fa2d-8b3e-4f5f-b378-f46b94b1494f
Public Version Date: November 18, 2021
Public Version Number: 3
DI Record Publish Date: May 31, 2020