Masimo

GUDID 10816317023499

LNCS Neonatal/Adult Probe-L 2321

RENU MEDICAL, INC

Pulse oximeter probe, reprocessed

• Primary Device ID: 10816317023499
• NIH Device Record Key: b31e66ea-7811-4c6c-b8cc-4c88b8ccd0f6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Masimo
• Version Model Number: RM-2321
• 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	00816317023492 [Primary]
GS1	10816317023499 [Package]; Contains: 00816317023492; 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