AccessGUDID - DEVICE: ATELLICA LID KEYING FEATURE KIT (00630414304328)

GUDID

Device Identifier (DI) Information

Brand Name: ATELLICA LID KEYING FEATURE KIT
Version or Model: 11597266
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 11597266
Company Name: Siemens Healthcare Diagnostics Inc.

Primary DI Number: 00630414304328
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 064608573 *Terms of Use

Device Description: ATELLICA CH LID KEYING FEATURE KIT

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?
62625	Instrument/analyser test tube rack cover IVD	A device intended to be used on-board an in vitro diagnostic laboratory instrument or analyser to secure test tubes placed onto an instrument/analyser test tube rack. It is typically made of plastic and is perforated to allow access to the contents of the test tubes. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JJE	ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE

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: without restrictions

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 45fdfed6-9dba-4521-adca-b8d10c0e16be
Public Version Date: May 27, 2022
Public Version Number: 1
DI Record Publish Date: May 19, 2022