RespArray NIBP cuff

GUDID 06944413839489

Edan Instruments, Inc.

Blood pressure cuff, reusable Blood pressure cuff, reusable Blood pressure cuff, reusable Blood pressure cuff, reusable Blood pressure cuff, reusable Blood pressure cuff, reusable Blood pressure cuff, reusable Blood pressure cuff, reusable Blood pressure cuff, reusable Blood pressure cuff, reusable Blood pressure cuff, reusable

• Primary Device ID: 06944413839489
• NIH Device Record Key: 7f03a05d-4988-498b-b707-4213b89d4669
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RespArray NIBP cuff
• Version Model Number: 02.57.225234
• 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	06944413839489 [Primary]

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