AccessGUDID - DEVICE: Atellica IM Calibrator D (00630414293561)

GUDID

Device Identifier (DI) Information

Brand Name: Atellica IM Calibrator D
Version or Model: 11206244
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 11206244
Company Name: Siemens Healthcare Diagnostics Inc.

Primary DI Number: 00630414293561
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 6
Labeler D-U-N-S® Number*: 064608573 *Terms of Use

Device Description: Calibrator D - Atellica IM - CAL (6PK) 6 x 2 x 2.0 mL

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?
38221	Multiple tissue-associated protein/tumour marker IVD, calibrator	A material which is used to establish known points of reference for a number of assays intended to be used for the qualitative and/or quantitative detection of one or multiple proteins or tumour markers associated with specific tissues in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LOK	KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
LOJ	KIT, TEST,ALPHA-FETOPROTEIN FOR TESTICULAR CANCER

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K020806	000
P930036	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

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: b8d25e63-05ed-4929-a196-1de4ea226ca9
Public Version Date: November 18, 2021
Public Version Number: 3
DI Record Publish Date: May 31, 2020