SPO2 AD CB,BCI RIDEL 7M,DB9F,2M 28569

GUDID 00840828189811

SPO2 AD CB,BCI RIDEL 7M,DB9F,2M

CURBELL MEDICAL PRODUCTS, INC.

Electrical-only medical device connection cable, reusable

• Primary Device ID: 00840828189811
• NIH Device Record Key: c3b43b14-5d79-478f-97e9-d88f6f63ef70
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SPO2 AD CB,BCI RIDEL 7M,DB9F,2M
• Version Model Number: OCT047
• Catalog Number: 28569
• Company DUNS: 796452311
• Company Name: CURBELL MEDICAL PRODUCTS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• 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	00840828189811 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K222370

FDA Product Code

• DSA: Cable, Transducer And Electrode, Patient, (Including Connector)
• ILQ: System, Communication, Powered

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: 2023-08-09
• Device Publish Date: 2023-08-01

Devices Manufactured by CURBELL MEDICAL PRODUCTS, INC.

• 00840828195966 - ZEPHYR,800,10,PUFF,JERON 680: 2026-02-19 ZEPHYR,800,10,PUFF,JERON 680
• 00840828195973 - ZEPHYR,800,10,SIP=N,PUFF=TV,JERON 680: 2026-02-19 ZEPHYR,800,10,SIP=N,PUFF=TV,JERON 680
• 00840828195980 - ZEPHYR,800,10,SIP=TV,PUFF=N,JERON 680: 2026-02-19 ZEPHYR,800,10,SIP=TV,PUFF=N,JERON 680
• 00840828195997 - ZEPHYR,800,10,SIP,JERON 680: 2026-02-19 ZEPHYR,800,10,SIP,JERON 680
• 00840828195904 - GEN4 PLUS, DIRECT ACCESS: 2026-02-11
• 00840828195911 - RESPONDER 5, INTERACTIVE: 2026-02-11
• 00840828180276 - 3701 P37,4FT,1TO1,90 DEG BED END,STKR: 2026-02-02 3701 P37,4FT,1TO1,90 DEG BED END,STKR
• 00840828180283 - 102 P37,2FT,NURSE ONLY,STKR: 2026-02-02 102 P37,2FT,NURSE ONLY,STKR