Nellcor

GUDID 30817357020145

Nellcor OxiMax Infant Pulse Oximeter Sensor

HYGIA HEALTH SERVICES, INC.

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• Primary Device ID: 30817357020145
• NIH Device Record Key: 175c3a28-8a47-4258-bbb1-16251e2ba9a5
• Commercial Distribution Discontinuation: 2019-07-31
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Nellcor
• Version Model Number: MAX-I
• Company DUNS: 177939027
• Company Name: HYGIA HEALTH SERVICES, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	10817357020141 [Primary]
GS1	30817357020145 [Package]; Contains: 10817357020141; Package: Box [24 Units]; Discontinued: 2021-03-19; Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K041867

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: 2021-03-19
• Device Publish Date: 2016-09-24

On-Brand Devices [Nellcor]

• 30817357020817: Nellcor Oxisensor Neonatal Pulse Oximeter Sensor
• 30817357020619: Nellcor Oxisensor Adult Pulse Oximeter Sensor
• 30817357020343: Nellcor OxiMax Adult Long Pulse Oximeter Sensor
• 30817357020299: Nellcor OxiMax Pediatric Pulse Oximeter Sensor
• 30817357020145: Nellcor OxiMax Infant Pulse Oximeter Sensor
• 30817357020022: Nellcor OxiMax Neonatal Pulse Oximeter Sensor
• 30817357020015: Nellcor OxiMax Adult Pulse Oximeter Sensor