Vermed

Basic Information

• Brand Name: Vermed
• Primary DI: 00009336006298
• Version / Model: PR-A520-1013P
• Catalog Number: PR-A520-1013P
• Company Name: GRAPHIC CONTROLS ACQUISITION CORP
• Labeler DUNS: 002111896
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: d782b3b1-99a4-4af7-8002-a632758879a0

Device Description

N Kohden comp.(new)Adult Reusable SpO2 Finger Sensor,5'/1.6m

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• 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
DQA	Oximeter	Cardiovascular	870.2700	2

GMDN Terms

Code	Name	Definition	Implantable	Status
17667	Telemetric pulse oximeter	A portable, photoelectric device intended for the transcutaneous monitoring of haemoglobin oxygen saturation (SpO2) through the radio transmission/reception of SpO2 values. The signals, typically produced by light-emitting diodes (LEDs) and a receiving detector in a probe, or directly built-in, are used to make the measurements using the principle of spectrophotometry. The oximeter displays the SpO2 values and may calculate/display other parameters, e.g., pulse rate, electrocardiogram (ECG) which are radio transmitted to a monitoring site to obviate the need for cabling, promoting the patient's freedom of movement.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00009336006298	GS1

Customer Contacts

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