Precision Xceed Pro

Basic Information

• Brand Name: Precision Xceed Pro
• Primary DI: 00093815709350
• Version / Model: 70935
• Catalog Number: 70935
• Company Name: ABBOTT DIABETES CARE INC
• Labeler DUNS: 966390890
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 50
• Record Status: Published
• Publish Date: 2016-07-22
• Public Version: 5
• Public Version Date: 2019-12-11
• Public Version Status: Update
• Public Device Record Key: b5710df3-4aaa-48f2-9d00-666e99978049

Device Description

Precision Xceed Pro Blood ß-Ketone Test Strips

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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
NBW	SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER	Clinical Chemistry	862.1345	2
JIN	NITROPRUSSIDE, KETONES (URINARY, NON-QUANT.)	Clinical Chemistry	862.1435	1
LFR	Glucose dehydrogenase, glucose	Clinical Chemistry	862.1345	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62644	Multiple clinical chemistry analyte monitoring system IVD, point-of-care	A collection of devices that includes one or more portable, electrically-powered instruments (meter), reagents, test strips and/or other associated materials and accessories [e.g., control solutions, lancets] intended to be used together exclusively at the point-of-care by medical professionals for the quantitative measurement of more than one clinical chemistry analyte [e.g., glucose, ketones, lipid(s), and/or creatinine] in a whole blood specimen. Some types may also include measurement of haemoglobin and/or haematocrit for rapid diagnosis of anaemia and/or blood loss.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	35021791709350	GS1	Case	12	In Commercial Distribution
Primary	00093815709350	GS1
Secondary	57599-0935-4	NDC/NHRIC
Unit of Use	10093815709357	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K080960	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 39 – 86 Degrees Fahrenheit