AccessGUDID - DEVICE: Atellica CH EMPTY2 (00630414604503)

GUDID

Device Identifier (DI) Information

Brand Name: Atellica CH EMPTY2
Version or Model: 11538115
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 11538115
Company Name: Siemens Healthcare Diagnostics Inc.

Primary DI Number: 00630414604503
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 8
Labeler D-U-N-S® Number*: 064608573 *Terms of Use

Device Description: Atellica CH EMPTY2

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?
61298	General laboratory assay tray	A tray with multiple wells designed to contain volumes of reagents, buffers, and other materials for laboratory testing procedures (e.g., in vitro diagnostic) performed manually, or by a laboratory analyser. The wells may in addition be used to contain and mix reactants for reactions performed onboard the analyser. It is typically made of plastic (e.g., polypropylene) and is used with manual or automated liquid handling instruments or analysers. This is a single-use device.	Obsolete	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 [?]
K151767	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
Handling Environment Temperature: between 2 and 30 Degrees Celsius
Storage Environment Temperature: between 2 and 30 Degrees Celsius
Special Storage Condition, Specify: Store Upright

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 501daa9e-a526-4718-a43f-19d7710dcbda
Public Version Date: January 19, 2022
Public Version Number: 4
DI Record Publish Date: February 05, 2021