Spectrum

GUDID 00844064035635

Aneroid Sphygmomanometer

RADIA ENTERPRISES, INC.

Aneroid manual sphygmomanometer

• Primary Device ID: 00844064035635
• NIH Device Record Key: 0caf50c4-9f4f-41b7-8cbe-f51823a505e8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Spectrum
• Version Model Number: SM109
• Company DUNS: 039675442
• Company Name: RADIA ENTERPRISES, INC.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 7136453600
• Email: sridhar@spectrumuniforms.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00844064035635 [Primary]
GS1	00844064056159 [Package]; Package: Cardboard box [50 Units]; In Commercial Distribution
GS1	00844064120171 [Package]; Package: Cardboard Box [25 Units]; In Commercial Distribution
GS1	00844064126739 [Package]; Package: Cardboard box [5 Units]; In Commercial Distribution
GS1	00844064126777 [Package]; Package: Cardboard box [30 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K090014

FDA Product Code

• DXN: System, Measurement, Blood-Pressure, Non-Invasive

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-12-10
• Device Publish Date: 2017-03-07

On-Brand Devices [Spectrum]

• 00844064035635: Aneroid Sphygmomanometer
• 00844064035550: Aneroid Sphygmomanometer