LEAF 66807745

GUDID 05000223503994

LEAF Hospital EMR System Integration Software Components

SMITH & NEPHEW MEDICAL LIMITED

Wireless patient monitor/sensor reporting software, professional-only

• Primary Device ID: 05000223503994
• NIH Device Record Key: ec9baf3d-ab04-473d-a1b0-c31f9b9b3046
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LEAF
• Version Model Number: 66807745
• Catalog Number: 66807745
• Company DUNS: 216344051
• Company Name: SMITH & NEPHEW MEDICAL LIMITED
• 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: false
• Serial Number: false
• Manufacturing Date: false
• 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)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM

Device Identifiers

Device Issuing Agency	Device ID
GS1	05000223503994 [Primary]

FDA Product Code

• KMI: MONITOR, BED PATIENT

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: 2026-03-09
• Device Publish Date: 2026-03-01

Devices Manufactured by SMITH & NEPHEW MEDICAL LIMITED

• 05000223503994 - LEAF: 2026-03-09LEAF Hospital EMR System Integration Software Components
• 05000223503994 - LEAF: 2026-03-09 LEAF Hospital EMR System Integration Software Components
• 00040565117706 - COVRSITE: 2026-01-27 COVRSITE DRESSING 4X4 BOX 10
• 00040565117744 - COVRSITE: 2026-01-27 CovRSite Dressing 6 x 6 CTN10
• 00040565120256 - COVRSITE: 2026-01-27 CovRSite Plus Dressing 4 x 4 CTN10
• 00040565120270 - COVRSITE: 2026-01-27 CovRSite Plus Dressing 6 x 6 CTN10
• 00500223504335 - NOVIX: 2026-01-21 NOVIX PRIMER AND CLEANSER 4OZ
• 05000223502713 - No Sting Skin Prep: 2025-12-04 NO-STING SKIN PREP SPRAY 28ML US
• 05000223499389 - RENASYS: 2025-10-01 RENASYS WOUND+ Dressing kit with AIRLOCK Technology with foam, large