LabTron

Basic Information

• Brand Name: LabTron
• Primary DI: M368202SX1
• Version / Model: 202S-X
• Company Name: GF HEALTH PRODUCTS, INC.
• Labeler DUNS: 132016168
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-08-31
• Public Version: 4
• Public Version Date: 2019-07-25
• Public Version Status: Update
• Public Device Record Key: 41893734-4a47-46bd-b1e0-2490a75f7ac4

Device Description

Labstar Deluxe Sphygmomanometer

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: Yes
• 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
DXQ	Blood Pressure Cuff	Cardiovascular	870.1120	2

GMDN Terms

Code	Name	Definition	Implantable	Status
16156	Aneroid manual sphygmomanometer	A device designed to measure blood pressure consisting of an inflatable cuff that fits around a limb (arm or thigh), an inflation bulb for controlling the air pressure within the cuff, an aneroid manometer, and tubing. The aneroid manometer consists of a metal bellows, which expands as the pressure in the cuff increases, and a mechanical amplifier that transmits this expansion through a lever to an indicator needle, which rotates around a circular, calibrated scale. The manometer may be mounted to a wall, placed on a table, or hand held (portable); blood pressure measurement is taken in conjunction with a stethoscope.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	M368202SX2	HIBCC		24	In Commercial Distribution
Primary	M368202SX1	HIBCC

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K092245	000

Storage Conditions

• Type: Storage Environment Humidity
• Temperature Range: – 85 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: -20 – 50 Degrees Celsius