DISP NLCR COMPAT SPO2 SNSR,OXMX,MAX-I 27078

GUDID 10840828184202

DISP NLCR COMPAT SPO2 SNSR,OXMX,MAX-I

CURBELL MEDICAL PRODUCTS, INC.

Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use

• Primary Device ID: 10840828184202
• NIH Device Record Key: 31f053d1-56d9-4ceb-a7d8-0d3255da7c10
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DISP NLCR COMPAT SPO2 SNSR,OXMX,MAX-I
• Version Model Number: CSA001DI-M300
• Catalog Number: 27078
• Company DUNS: 796452311
• Company Name: CURBELL MEDICAL PRODUCTS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• 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

Customer Support Contacts

• Phone: 1-800-235-7500
• Email: mwinter@curbellmedical.com
• Phone: 1-800-235-7500
• Email: mwinter@curbellmedical.com
• Phone: 1-800-235-7500
• Email: mwinter@curbellmedical.com
• Phone: 1-800-235-7500
• Email: mwinter@curbellmedical.com
• Phone: 1-800-235-7500
• Email: mwinter@curbellmedical.com
• Phone: 1-800-235-7500
• Email: mwinter@curbellmedical.com
• Phone: 1-800-235-7500
• Email: mwinter@curbellmedical.com
• Phone: 1-800-235-7500
• Email: mwinter@curbellmedical.com
• Phone: 1-800-235-7500
• Email: mwinter@curbellmedical.com
• Phone: 1-800-235-7500
• Email: mwinter@curbellmedical.com
• Phone: 1-800-235-7500
• Email: mwinter@curbellmedical.com
• Phone: 1-800-235-7500
• Email: mwinter@curbellmedical.com
• Phone: 1-800-235-7500
• Email: mwinter@curbellmedical.com
• Phone: 1-800-235-7500
• Email: mwinter@curbellmedical.com
• Phone: 1-800-235-7500
• Email: mwinter@curbellmedical.com
• Phone: 1-800-235-7500
• Email: mwinter@curbellmedical.com
• Phone: 1-800-235-7500
• Email: mwinter@curbellmedical.com
• Phone: 1-800-235-7500
• Email: mwinter@curbellmedical.com
• Phone: 1-800-235-7500
• Email: mwinter@curbellmedical.com
• Phone: 1-800-235-7500
• Email: mwinter@curbellmedical.com
• Phone: 1-800-235-7500
• Email: mwinter@curbellmedical.com
• Phone: 1-800-235-7500
• Email: mwinter@curbellmedical.com
• Phone: 1-800-235-7500
• Email: mwinter@curbellmedical.com
• Phone: 1-800-235-7500
• Email: mwinter@curbellmedical.com
• Phone: 1-800-235-7500
• Email: mwinter@curbellmedical.com
• Phone: 1-800-235-7500
• Email: mwinter@curbellmedical.com
• Phone: 1-800-235-7500
• Email: mwinter@curbellmedical.com
• Phone: 1-800-235-7500
• Email: mwinter@curbellmedical.com
• Phone: 1-800-235-7500
• Email: mwinter@curbellmedical.com
• Phone: 1-800-235-7500
• Email: mwinter@curbellmedical.com
• Phone: 1-800-235-7500
• Email: mwinter@curbellmedical.com
• Phone: 1-800-235-7500
• Email: mwinter@curbellmedical.com
• Phone: 1-800-235-7500
• Email: mwinter@curbellmedical.com
• Phone: 1-800-235-7500
• Email: mwinter@curbellmedical.com
• Phone: 1-800-235-7500
• Email: mwinter@curbellmedical.com
• Phone: 1-800-235-7500
• Email: mwinter@curbellmedical.com
• Phone: 1-800-235-7500
• Email: mwinter@curbellmedical.com
• Phone: 1-800-235-7500
• Email: mwinter@curbellmedical.com
• Phone: 1-800-235-7500
• Email: mwinter@curbellmedical.com
• Phone: 1-800-235-7500
• Email: mwinter@curbellmedical.com
• Phone: 1-800-235-7500
• Email: mwinter@curbellmedical.com
• Phone: 1-800-235-7500
• Email: mwinter@curbellmedical.com
• Phone: 1-800-235-7500
• Email: mwinter@curbellmedical.com
• Phone: 1-800-235-7500
• Email: mwinter@curbellmedical.com
• Phone: 1-800-235-7500
• Email: mwinter@curbellmedical.com
• Phone: 1-800-235-7500
• Email: mwinter@curbellmedical.com
• Phone: 1-800-235-7500
• Email: mwinter@curbellmedical.com
• Phone: 1-800-235-7500
• Email: mwinter@curbellmedical.com
• Phone: 1-800-235-7500
• Email: mwinter@curbellmedical.com
• Phone: 1-800-235-7500
• Email: mwinter@curbellmedical.com
• Phone: 1-800-235-7500
• Email: mwinter@curbellmedical.com
• Phone: 1-800-235-7500
• Email: mwinter@curbellmedical.com
• Phone: 1-800-235-7500
• Email: mwinter@curbellmedical.com
• Phone: 1-800-235-7500
• Email: mwinter@curbellmedical.com
• Phone: 1-800-235-7500
• Email: mwinter@curbellmedical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840828184205 [Primary]
GS1	00840828189415 [Package]; Contains: 00840828184205; Package: Case [24 Units]; In Commercial Distribution
GS1	10840828184202 [Package]; Contains: 00840828184205; Package: CASE [30 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182220

FDA Product Code

• DQA: Oximeter
• DSA: Cable, Transducer And Electrode, Patient, (Including Connector)

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: 2021-09-23
• Device Publish Date: 2021-09-15

On-Brand Devices [DISP NLCR COMPAT SPO2 SNSR,OXMX,MAX-I]

• 00840828180580: DISP NLCR COMPAT SPO2 SNSR,OXMX,MAX-I
• 10840828184202: DISP NLCR COMPAT SPO2 SNSR,OXMX,MAX-I