NA

Basic Information

• Brand Name: NA
• Primary DI: 00840682103480
• Version / Model: NMT Pediatric MechanoSensor, 897439
• Company Name: GE Healthcare Finland Oy
• Labeler DUNS: 401966697
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-06-16
• Public Version: 4
• Public Version Date: 2023-12-18
• Public Version Status: Update
• Public Device Record Key: 096b9446-090d-43e6-b771-e3ad7014fab6

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
KOI	STIMULATOR, NERVE, PERIPHERAL, ELECTRIC	Anesthesiology	868.2775	2

GMDN Terms

Code	Name	Definition	Implantable	Status
59692	Neuromuscular transmission motion sensor	A device intended to be placed on the thumb and index finger of a patient to detect movements and convert them into electrical neuromuscular transmission (NMT) signals during nerve stimulation. The device, also known as a mechanosensor, is a piezoelectric sensor that functions with an NMT sensor cable and skin surface NMT electrodes to transmit electrical signals to a patient monitoring module dedicated to the monitoring of patient relaxation to determine level of neuromuscular block. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00840682103480	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K051635	000