BIS

Basic Information

• Brand Name: BIS
• Primary DI: 10884521134478
• Version / Model: 186-0212
• Company Name: Covidien LP
• Labeler DUNS: 058614483
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-25
• Public Version: 14
• Public Version Date: 2024-02-26
• Public Version Status: Update
• Public Device Record Key: 5de3792a-8258-4ee0-a0e0-b7d7a716758b

Device Description

BILATERAL SENSOR

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: Yes
• 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
GXY	Electrode, Cutaneous	Neurology	882.1320	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46620	Cerebral oximeter sensor, single-use	A photoelectric device designed to be applied externally to the scalp/head of a patient for transcutaneous measurement [e.g., using near-infrared spectroscopy (NIRS)] of brain tissue blood oxygen saturation and/or venous oxygen saturation in the brain. It connects to a cerebral oximeter via a fibreoptic cable and typically consists of a single/dual adhesive sensing strip. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10884521134478	GS1
Package	90884521657850	GS1	PALLET	9999	In Commercial Distribution
Package	30884521657858	GS1	PACK_OR_INNER_PACK	10	In Commercial Distribution
Package	20884521134475	GS1	CASE	10	In Commercial Distribution

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K062692	000
K143506	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 50 – 85 Degrees Fahrenheit