Spectrum

Basic Information

• Brand Name: Spectrum
• Primary DI: 00844064035635
• Version / Model: SM109
• Company Name: RADIA ENTERPRISES, INC.
• Labeler DUNS: 039675442
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-03-07
• Public Version: 4
• Public Version Date: 2018-12-10
• Public Version Status: Update
• Public Device Record Key: 0caf50c4-9f4f-41b7-8cbe-f51823a505e8

Device Description

Aneroid Sphygmomanometer

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): Yes
• 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: Yes
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	870.1130	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
Primary	00844064035635	GS1
Package	00844064120171	GS1	Cardboard Box	25	In Commercial Distribution
Package	00844064126739	GS1	Cardboard box	5	In Commercial Distribution
Package	00844064126777	GS1	Cardboard box	30	In Commercial Distribution
Package	00844064056159	GS1	Cardboard box	50	In Commercial Distribution

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K090014	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -20 – 70 Degrees Celsius