Generic 100-0341-002

GUDID 00810025360023

Adult - Blood Pressure Cuff with Gauge/bladder and tubing. - Noir/Black with zipper case.

MAGNUM MEDICAL, INC.

Aneroid manual sphygmomanometer

• Primary Device ID: 00810025360023
• NIH Device Record Key: 2bb1893a-9545-4854-9f0a-24ecf49ffd5e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Generic
• Version Model Number: Adult
• Catalog Number: 100-0341-002
• Company DUNS: 603065293
• Company Name: MAGNUM MEDICAL, INC.
• Device Count: 1
• DM Exempt: false
• 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: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810025360023 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K082542

FDA Product Code

• DXQ: Blood Pressure Cuff

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-10-04
• Device Publish Date: 2019-09-26

On-Brand Devices [Generic]

• 00810025360030: Adult Aneroid (Blood pressure cuff with tubing and gauge - Various Colors) in a zipper bag.
• 00810025360023: Adult - Blood Pressure Cuff with Gauge/bladder and tubing. - Noir/Black with zipper case.