AccessGUDID - DEVICE: Atellica CH MULTIDRUG QC (00630414002699)

GUDID

Device Identifier (DI) Information

Brand Name: Atellica CH MULTIDRUG QC
Version or Model: 11099406
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 11099406
Company Name: Siemens Healthcare Diagnostics Inc.

Primary DI Number: 00630414002699
Issuing Agency: GS1
Commercial Distribution End Date: July 26, 2022
Device Count: 3
Labeler D-U-N-S® Number*: 064608573 *Terms of Use

Device Description: Multi-drug QC (Urine) Atellica CH - CTL 3 x 5mL

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?
30503	Multiple therapeutic drugs/drugs of abuse IVD, control	A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of multiple therapeutic drugs and drugs of abuse in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DIF	Drug mixture control materials

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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: 438fca61-52c4-44e8-a5bc-f66010a1678a
Public Version Date: March 30, 2023
Public Version Number: 3
DI Record Publish Date: September 24, 2020