Atellica CH EMPTY2

Basic Information

• Brand Name: Atellica CH EMPTY2
• Primary DI: 00630414604503
• Version / Model: 11538115
• Catalog Number: 11538115
• Company Name: Siemens Healthcare Diagnostics Inc.
• Labeler DUNS: 064608573
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 8
• Record Status: Published
• Publish Date: 2021-02-05
• Public Version: 4
• Public Version Date: 2022-01-19
• Public Version Status: Update
• Public Device Record Key: 501daa9e-a526-4718-a43f-19d7710dcbda

Device Description

Atellica CH EMPTY2

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JJE	ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE	Clinical Chemistry	862.2160	1

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	00630414297682	GS1
Primary	00630414604503	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K151767	000

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: 2 – 30 Degrees Celsius
• Type: Storage Environment Temperature
• Temperature Range: 2 – 30 Degrees Celsius
• Type: Special Storage Condition, Specify
• Special Conditions: Store Upright