STAT PROFILE

Basic Information

• Brand Name: STAT PROFILE
• Primary DI: 00385480489355
• Version / Model: phox ultra/ccx
• Catalog Number: 48935
• Company Name: NOVA BIOMEDICAL CORPORATION
• Labeler DUNS: 070617139
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 30
• Record Status: Published
• Publish Date: 2016-09-16
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 4454f39b-7535-4f11-b1d9-2a41320d7618

Device Description

Stat Profile pHOx Ultra/CCX Blood Gas Controls Multipack L1, 2, 3 (Amps)

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• 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: Yes
• 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
JJY	Multi-analyte controls, all kinds (assayed)	Clinical Chemistry	862.1660	1

GMDN Terms

Code	Name	Definition	Implantable	Status
56660	Assisted reproduction centrifuge tube	A sterile container (a dedicated sealable centrifuge tube) intended for the preparation, centrifuging and storage of biological samples used in assisted reproduction techniques (ART), e.g., sperm. It is intended for use in assisted reproduction clinics and is specific to the procedure(s) and policies used in, in vitro fertilization (IVF). Its main application being the separation of unwanted biological material of human origin, e.g., by adding semen and a gradient to the biological material in the tube and applying centrifugation, this facilitates the removal of seminal plasma, dead sperm and other cells; spermatozoa of highest mobility can be thus selected. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00385480489355	GS1
Unit of Use	00385489489356	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K110648	000

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: 24 – 26 Degrees Celsius
• Type: Special Storage Condition, Specify
• Special Conditions: Do not freeze
• Type: Storage Environment Temperature
• Temperature Range: 15 – 30 Degrees Celsius