AccessGUDID - DEVICE: Atellica IM DHEAS2 MCM SET (00630414632940)

GUDID

Device Identifier (DI) Information

Brand Name: Atellica IM DHEAS2 MCM SET
Version or Model: 11209195
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 11209195
Company Name: Siemens Healthcare Diagnostics Inc.

Primary DI Number: 00630414632940
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 064608573 *Terms of Use

Device Description: Atellica IM DHEASII MCM SET

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?
54141	Dehydroepiandrosterone sulfate (DHEAS) IVD, control	A material which is used to verify the performance of an assay intended to be used for the quantitative measurement of dehydroepiandrosterone sulfate (DHEAS) in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JJX	Single (specified) analyte controls (assayed and unassayed)

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
Special Storage Condition, Specify: Store upright, protect from light, do not freeze, resuspend.
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: d122a506-06ee-4123-a690-7bc93295dec2
Public Version Date: March 28, 2025
Public Version Number: 1
DI Record Publish Date: March 20, 2025