RespArray NIBP cuff

GUDID 06944413839465

Edan Instruments, Inc.

Blood pressure cuff, reusable

• Primary Device ID: 06944413839465
• NIH Device Record Key: c5a1bd79-5f94-4846-9538-3d9b4efb2716
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RespArray NIBP cuff
• Version Model Number: 02.57.225232
• Company DUNS: 529173163
• Company Name: Edan Instruments, 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: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06944413839465 [Primary]
GS1	16944413839462 [Package]; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K220308

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: 2024-04-29
• Device Publish Date: 2024-04-19

On-Brand Devices [RespArray NIBP cuff]

• 06944413824812: 01.57.472318
• 06944413824805: 01.57.472317
• 06944413839496: 02.57.225235
• 06944413839489: 02.57.225234
• 06944413839472: 02.57.225233
• 06944413839465: 02.57.225232
• 06944413839458: 02.57.225240
• 06944413839441: 02.57.225241
• 06944413839434: 02.57.225242