NA

Basic Information

• Brand Name: NA
• Primary DI: 00840682103718
• Version / Model: OXY-HB
• Company Name: GE Healthcare Finland Oy
• Labeler DUNS: 401966697
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-06-29
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: af315d5a-14b6-49c2-afea-290f0595c1c0

Device Characteristics

• Single Use: No
• 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: MR Unsafe
• 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
DPZ	Oximeter, ear	Cardiovascular	870.2710	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35709	Electrode/transducer strap, reusable	A strip of material (e.g., fabric) intended to be used to hold electrodes and/or transducers (e.g., foetal monitoring transducers) in place on the body surface; it typically has fasteners (e.g., Velcro, buckle). This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00840682103718	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K040831	000