CueSee® Hypoxic

Basic Information

• Brand Name: CueSee® Hypoxic
• Primary DI: 08718734960652
• Version / Model: CueSee® Hypoxic X-Low
• Catalog Number: 166.001.005
• Company Name: Eurotrol B.V.
• Labeler DUNS: 412925992
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-10-08
• Public Version: 1
• Public Version Date: 2020-10-16
• Public Version Status: New
• Public Device Record Key: 900ddfd9-46bd-4857-9b0e-2777943e68d9

Device Description

CueSee® Hypoxic is a pre-tonometered bovine hemoglobin (Hb) quality control material for professional use for monitoring blood gas analyzers’ performance of Oxygen partial pressure (pO2).

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: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JJS	Controls For Blood-Gases, (Assayed And Unassayed)	Clinical Chemistry	862.1660	1

GMDN Terms

Code	Name	Definition	Implantable	Status
30218	Multiple blood gas analyte IVD, control	A material which is used to verify the performance of a number of assays intended to be used for the quantitative measurement of one or multiple blood gas analytes in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	08718734960669	GS1	Product Box	5	In Commercial Distribution
Primary	08718734960652	GS1

Premarket Submissions

Submission Number	Supplement Number
K152553	000