Masimo Pulse Oximeter Probe

GUDID 10816317020450

LNCS Infant Probe-L 1861

RENU MEDICAL, INC

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• Primary Device ID: 10816317020450
• NIH Device Record Key: 245f02ee-5508-4f34-a0c8-3db7a890e72a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Masimo Pulse Oximeter Probe
• Version Model Number: RM-1861
• Company DUNS: 100439103
• Company Name: RENU MEDICAL, INC
• Device Count: 1
• DM Exempt: true
• 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	00816317020453 [Primary]
GS1	10816317020450 [Package]; Contains: 00816317020453; 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: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-08-02
• Device Publish Date: 2016-05-16

On-Brand Devices [Masimo Pulse Oximeter Probe]

• 10861317020511: LNCS Neonatal/Adult Probe
• 10861317020504: LNCS Infant Probe
• 10861317020498: LNCS Neonatal/Adult Probe-L
• 10861317020481: LNCS Infant Probe-L
• 10861317020474: LNCS Adult Probe-L
• 10861317020467: LNCS Neonatal/Adult Probe-L 1862
• 10861317020450: LNCS Infant Probe-L 1861
• 10861317020443: LNCS Adult Probe
• 10816317020511: LNCS Neonatal/Adult Probe
• 10816317020504: LNCS Infant Probe
• 10816317020498: LNCS Neonatal/Adult Probe-L
• 10816317020481: LNCS Infant Probe-L
• 10816317020474: LNCS Adult Probe-L
• 10816317020467: LNCS Neonatal/Adult Probe-L 1862
• 10816317020450: LNCS Infant Probe-L 1861
• 10816317020443: LNCS Adult Probe