Masimo

GUDID 10816317023970

LNCS Pediatric Probe

RENU MEDICAL, INC

Pulse oximeter probe, reprocessed Pulse oximeter probe, reprocessed Pulse oximeter probe, reprocessed Pulse oximeter probe, reprocessed Pulse oximeter probe, reprocessed Pulse oximeter probe, reprocessed Pulse oximeter probe, reprocessed Pulse oximeter probe, reprocessed Pulse oximeter probe, reprocessed Pulse oximeter probe, reprocessed Pulse oximeter probe, reprocessed Pulse oximeter probe, reprocessed Pulse oximeter probe, reprocessed Pulse oximeter probe, reprocessed Pulse oximeter probe, reprocessed Pulse oximeter probe, reprocessed Pulse oximeter probe, reprocessed Pulse oximeter probe, reprocessed Pulse oximeter probe, reprocessed Pulse oximeter probe, reprocessed Pulse oximeter probe, reprocessed Pulse oximeter probe, reprocessed Pulse oximeter probe, reprocessed Pulse oximeter probe, reprocessed Pulse oximeter probe, reprocessed Pulse oximeter probe, reprocessed Pulse oximeter probe, reprocessed Pulse oximeter probe, reprocessed Pulse oximeter probe, reprocessed Pulse oximeter probe, reprocessed Pulse oximeter probe, reprocessed Pulse oximeter probe, reprocessed

• Primary Device ID: 10816317023970
• NIH Device Record Key: 14abb235-8691-48cd-9187-cb658ee13b97
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Masimo
• Version Model Number: RM-1860
• Company DUNS: 100439103
• Company Name: RENU MEDICAL, INC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816317023973 [Primary]
GS1	10816317023970 [Package]; Contains: 00816317023973; Package: Case [20 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K081927

FDA Product Code

• NLF: Oximeter, Reprocessed

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: 2023-07-07
• Device Publish Date: 2023-06-29

On-Brand Devices [Masimo]

• 10816317023970: LNCS Pediatric Probe
• 10816317023499: LNCS Neonatal/Adult Probe-L 2321