NIBP tube

GUDID 06944413812048

Edan Instruments, Inc.

Blood pressure cuff, reusable

• Primary Device ID: 06944413812048
• NIH Device Record Key: c142d147-65cc-457d-932f-0d1237f2c6fb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NIBP tube
• Version Model Number: 01.57.471908
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06944413812048 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202892

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: 2021-02-09
• Device Publish Date: 2021-02-01

On-Brand Devices [NIBP tube]

• 06944413807334: NIBP Tube, 3m
• 06944413807327: NIBP tube for cuff,3m
• 06944413807310: NIBP Tube for neonatal cuff, 3m
• 06944413804951: NIBP Tube for neonatal cuff, 3m
• 06944413804944: NIBP Tube for neonatal cuff, 3m
• 06944413804937: NIBP Tube for neonatal cuff, 3m
• 06944413804920: NIBP Tube for neonatal cuff, 3m
• 06944413804807: NIBP Tube, 3m
• 06944413804791: NIBP Tube, 3m
• 06944413812048: 01.57.471908