AccessGUDID - DEVICE: Atellica CH TDM Calibrator (00630414597607)

GUDID

Device Identifier (DI) Information

Brand Name: Atellica CH TDM Calibrator
Version or Model: 11099439
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 11099439
Company Name: Siemens Healthcare Diagnostics Inc.

Primary DI Number: 00630414597607
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 064608573 *Terms of Use

Device Description: TDM Calibrator Atellica CH - CAL 5 x 2 x 3.0mL

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?
55234	Multiple-therapy therapeutic drug monitoring IVD, calibrator	A material which is used to establish known points of reference for an assay intended to be used for the quantitative measurement and therapeutic monitoring of multiple drugs used for different types of therapies (e.g., antibiotic, anticonvulsant, and cardiovascular) in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DKB	Calibrators, drug mixture

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K012318	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: Protect From Light
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: 26d0867b-1884-46c3-8b6c-3b77f4094aa2
Public Version Date: November 18, 2021
Public Version Number: 5
DI Record Publish Date: February 06, 2018