ADVIA® Chemistry ISE Buffer

Basic Information

• Brand Name: ADVIA® Chemistry ISE Buffer
• Primary DI: 00630414526768
• Version / Model: 10321715
• Catalog Number: 4997873
• Company Name: Siemens Healthcare Diagnostics Inc.
• Labeler DUNS: 064608573
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-09-24
• Public Version: 2
• Public Version Date: 2021-11-18
• Public Version Status: Update
• Public Device Record Key: 7e78f691-e52f-4b34-be98-a56539040607

Device Description

ISE Buffer Large - ADVIA Chem. - CONS - 3 Liter

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: Yes
• 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
JCC	PH BUFFER	Pathology	864.4010	1

GMDN Terms

Code	Name	Definition	Implantable	Status
42693	pH-adjusted buffer solution IVD	A pH-adjusted buffer solution intended to be used alone or in combination with other IVDs in the processing, staining, and/or testing of clinical laboratory specimens.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00630414526768	GS1

Customer Contacts

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