DISP NLCR COMPAT SPO2 SNSR,NON OXMX,D-20 26254

GUDID 00840828180672

DISP NLCR COMPAT SPO2 SNSR,NON OXMX,D-20

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 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: 00840828180672
• NIH Device Record Key: 8c1c2b83-1798-4d63-89b0-224052bb7c8d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DISP NLCR COMPAT SPO2 SNSR,NON OXMX,D-20
• Version Model Number: CSA001DP-P100
• Catalog Number: 26254
• 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
• 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	00840828180672 [Primary]
GS1	00840828189538 [Package]; Package: Case [24 Units]; In Commercial Distribution
GS1	10840828180679 [Package]; 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: 2020-08-17
• Device Publish Date: 2020-08-07

Devices Manufactured by CURBELL MEDICAL PRODUCTS, INC.

• 00840828182294 - REUS,NCLR OXSMRT SPO2 SNSR,9.5',LG CLAM: 2024-04-18 REUS,NCLR OXSMRT SPO2 SNSR,9.5',LG CLAM
• 00840828182300 - REUS,NLCR OXSMRT SPO2 SNSR,3.3',LG CLAM: 2024-04-18 REUS,NLCR OXSMRT SPO2 SNSR,3.3',LG CLAM
• 00840828182317 - REUS,NLCR OXSMRT SPO2 SNSR,3.3',LG SOFT: 2024-04-18 REUS,NLCR OXSMRT SPO2 SNSR,3.3',LG SOFT
• 00840828182324 - REUS,NLCR OXSMRT SPO2 SNSR,3.3',SM SOFT: 2024-04-18 REUS,NLCR OXSMRT SPO2 SNSR,3.3',SM SOFT
• 00840828182331 - REUS,NLCR OXMAX SPO2 SNSR,9.5',LG CLAM: 2024-04-18 REUS,NLCR OXMAX SPO2 SNSR,9.5',LG CLAM
• 00840828182348 - REUS,NLCR OXMAX SPO2 SNSR,3.3',LG CLAM: 2024-04-18 REUS,NLCR OXMAX SPO2 SNSR,3.3',LG CLAM
• 00840828182355 - REUS,NLCR OXMAX SPO2 SNSR,9.5',LG SOFT: 2024-04-18 REUS,NLCR OXMAX SPO2 SNSR,9.5',LG SOFT
• 00840828182362 - REUS,NLCR OXMAX SPO2 SNSR,3.3',LG SOFT: 2024-04-18 REUS,NLCR OXMAX SPO2 SNSR,3.3',LG SOFT