REUS,NK SPO2 SNSR,63",W WRAP 28191

GUDID 00840828187671

REUS,NK SPO2 SNSR,63",W WRAP

CURBELL MEDICAL PRODUCTS, INC.

Pulse oximeter probe, reusable

• Primary Device ID: 00840828187671
• NIH Device Record Key: 0702b7c6-7b02-4092-9707-6186de23c52c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: REUS,NK SPO2 SNSR,63",W WRAP
• Version Model Number: CSW027CN
• Catalog Number: 28191
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• 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@curbell.com
• Phone: 1-800-235-7500
• Email: mwinter@curbell.com
• Phone: 1-800-235-7500
• Email: mwinter@curbell.com
• Phone: 1-800-235-7500
• Email: mwinter@curbell.com
• Phone: 1-800-235-7500
• Email: mwinter@curbell.com
• Phone: 1-800-235-7500
• Email: mwinter@curbell.com
• Phone: 1-800-235-7500
• Email: mwinter@curbell.com
• Phone: 1-800-235-7500
• Email: mwinter@curbell.com
• Phone: 1-800-235-7500
• Email: mwinter@curbell.com
• Phone: 1-800-235-7500
• Email: mwinter@curbell.com
• Phone: 1-800-235-7500
• Email: mwinter@curbell.com
• Phone: 1-800-235-7500
• Email: mwinter@curbell.com
• Phone: 1-800-235-7500
• Email: mwinter@curbell.com
• Phone: 1-800-235-7500
• Email: mwinter@curbell.com
• Phone: 1-800-235-7500
• Email: mwinter@curbell.com
• Phone: 1-800-235-7500
• Email: mwinter@curbell.com
• Phone: 1-800-235-7500
• Email: mwinter@curbell.com
• Phone: 1-800-235-7500
• Email: mwinter@curbell.com
• Phone: 1-800-235-7500
• Email: mwinter@curbell.com
• Phone: 1-800-235-7500
• Email: mwinter@curbell.com
• Phone: 1-800-235-7500
• Email: mwinter@curbell.com
• Phone: 1-800-235-7500
• Email: mwinter@curbell.com
• Phone: 1-800-235-7500
• Email: mwinter@curbell.com
• Phone: 1-800-235-7500
• Email: mwinter@curbell.com
• Phone: 1-800-235-7500
• Email: mwinter@curbell.com
• Phone: 1-800-235-7500
• Email: mwinter@curbell.com
• Phone: 1-800-235-7500
• Email: mwinter@curbell.com
• Phone: 1-800-235-7500
• Email: mwinter@curbell.com
• Phone: 1-800-235-7500
• Email: mwinter@curbell.com
• Phone: 1-800-235-7500
• Email: mwinter@curbell.com
• Phone: 1-800-235-7500
• Email: mwinter@curbell.com
• Phone: 1-800-235-7500
• Email: mwinter@curbell.com
• Phone: 1-800-235-7500
• Email: mwinter@curbell.com
• Phone: 1-800-235-7500
• Email: mwinter@curbell.com
• Phone: 1-800-235-7500
• Email: mwinter@curbell.com
• Phone: 1-800-235-7500
• Email: mwinter@curbell.com
• Phone: 1-800-235-7500
• Email: mwinter@curbell.com
• Phone: 1-800-235-7500
• Email: mwinter@curbell.com
• Phone: 1-800-235-7500
• Email: mwinter@curbell.com
• Phone: 1-800-235-7500
• Email: mwinter@curbell.com
• Phone: 1-800-235-7500
• Email: mwinter@curbell.com
• Phone: 1-800-235-7500
• Email: mwinter@curbell.com
• Phone: 1-800-235-7500
• Email: mwinter@curbell.com
• Phone: 1-800-235-7500
• Email: mwinter@curbell.com
• Phone: 1-800-235-7500
• Email: mwinter@curbell.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840828187671 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K103685

FDA Product Code

• DQA: Oximeter

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2024-04-18
• Device Publish Date: 2023-01-13

Devices Manufactured by CURBELL MEDICAL PRODUCTS, INC.

• 00840828195430 - GEN4 PLUS, DIRECT ACCESS: 2025-12-12
• 00840828195447 - RESPONDER 5, INTERACTIVE: 2025-12-12
• 00840828195454 - GEN4 INTERACTIVE: 2025-12-12
• 00840828195478 - RESPONDER 5, INTERACTIVE: 2025-12-12
• 00840828195416 - UNDER BED LIGHT CONTROLLER ASSEMBLY: 2025-12-03
• 00840828195423 - SAFE MOBILITY LIGHT KIT,XMIT,PAD,PWR 8': 2025-12-03
• 00840828195409 - P102, P102 & S102, 6", DP, CURBELL: 2025-11-28
• 00840828195331 - RESPONDER 5, INTERACTIVE: 2025-11-19