Atellica CH GluO

Basic Information

• Brand Name: Atellica CH GluO
• Primary DI: 00630414595634
• Version / Model: 11097621
• Catalog Number: 11097621
• Company Name: Siemens Healthcare Diagnostics Inc.
• Labeler DUNS: 064608573
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 4
• Record Status: Published
• Publish Date: 2017-12-21
• Public Version: 6
• Public Version Date: 2023-07-06
• Public Version Status: Update
• Public Device Record Key: 46fe95f9-f530-4867-a510-d37d0cfba58c

Device Description

Glucose Oxidase (GluO) - Atellica CH - RGT - 5600T

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
CGA	GLUCOSE OXIDASE, GLUCOSE	Clinical Chemistry	862.1345	2

GMDN Terms

Code	Name	Definition	Implantable	Status
53301	Glucose IVD, kit, spectrophotometry	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of glucose in a clinical specimen, using a spectrophotometry method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00630414595634	GS1
Unit of Use	00630414007250	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K042015	000

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Protect From Light
• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius