DISP NONN COMP SPO2 SNSR,6000CI,INFT,39" 28793

GUDID 10840828190463

DISP NONIN COMP SPO2 SNSR,6000CI,INFANT,39”,NONWVN FABRIC,NON-STRL,EA

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

• Primary Device ID: 10840828190463
• NIH Device Record Key: 17c0dcbe-1b00-4410-9635-90c7a9292f71
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DISP NONN COMP SPO2 SNSR,6000CI,INFT,39"
• Version Model Number: CSA020DI-M200
• Catalog Number: 28793
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840828190466 [Primary]
GS1	10840828190463 [Package]; Contains: 00840828190466; Package: Case [24 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K103685
• 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: 2023-11-15
• Device Publish Date: 2023-11-07

Devices Manufactured by CURBELL MEDICAL PRODUCTS, INC.

• 00840828187749 - RLW,3PK,SNAP,SAFETY DIN,24",AHA: 2024-06-06 RLW,3PK,SNAP,SAFETY DIN,24",AHAL)
• 00840828187756 - RLW,3PK,SNAP,SAFETY DIN,40",AHA: 2024-06-06 RLW,3PK,SNAP,SAFETY DIN,40",AHA
• 00840828187763 - RLW,5PK,SNAP,SAFETY DIN,18",AHA: 2024-06-06 RLW,5PK,SNAP,SAFETY DIN,18",AHA
• 00840828187770 - RLW,5PK,SNAP,SAFETY DIN,24",AHA: 2024-06-06 RLW,5PK,SNAP,SAFETY DIN,24",AHA
• 00840828187787 - RLW,5PK,SNAP,SAFETY DIN,40",AHA: 2024-06-06 RLW,5PK,SNAP,SAFETY DIN,40",AHA
• 00840828187947 - RLW,3PK,PINCH,SAFETY DIN,24",AHA: 2024-06-06 RLW,3PK,PINCH,SAFETY DIN,24",AHA
• 00840828187954 - RLW,3PK,PINCH,SAFETY DIN,40",AHA: 2024-06-06 RLW,3PK,PINCH,SAFETY DIN,40",AHA
• 00840828187961 - RLW,5PK,PINCH,SAFETY DIN,24",AHA: 2024-06-06 RLW,5PK,PINCH,SAFETY DIN,24",AHA