Nellcor Pulse Oximeter Probe

GUDID 10816317020559

Nellcor OxiMax MAX-I INFANT

RENU MEDICAL, INC

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• Primary Device ID: 10816317020559
• NIH Device Record Key: 6010c43f-5a21-438b-8d26-e130e311d7dc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Nellcor Pulse Oximeter Probe
• Version Model Number: RM-MAX-I
• 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	00816317020552 [Primary]
GS1	10816317020559 [Package]; Contains: 00816317020552; Package: CASE [24 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111773

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: 2016-08-23

On-Brand Devices [Nellcor Pulse Oximeter Probe]

• 10861317020566: Nellcor OxiMax MAX-N NEONATAL/ADULT
• 10861317020559: Nellcor OxiMax MAX-I INFANT
• 10861317020542: Nellcor OxiMax MAX-AL ADULT
• 10861317020535: Nellcor OxiMax MAX-A ADULT
• 10861317020528: Nellcor Oxisensor D-25
• 10816317020566: Nellcor OxiMax MAX-N NEONATAL/ADULT
• 10816317020559: Nellcor OxiMax MAX-I INFANT
• 10816317020542: Nellcor OxiMax MAX-AL ADULT
• 10816317020535: Nellcor OxiMax MAX-A ADULT
• 10816317020528: Nellcor Oxisensor D-25