Masimo

GUDID 30817357020978

Masimo Infant SpO2 Adhesive Sensors, 3 ft.

HYGIA HEALTH SERVICES, 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

• Primary Device ID: 30817357020978
• NIH Device Record Key: 8975636b-d928-47e3-8cd4-d3e9cb9665f5
• Commercial Distribution Discontinuation: 2019-07-31
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Masimo
• Version Model Number: 2319
• 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	10817357020974 [Primary]
GS1	30817357020978 [Package]; Contains: 10817357020974; Package: Box [20 Units]; Discontinued: 2021-03-19; Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K080424

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 [Masimo]

• 30817357021418: Masimo Infant SpO2 Adhesive Sensors, 3 ft.
• 30817357020978: Masimo Infant SpO2 Adhesive Sensors, 3 ft.
• 30817357020725: Masimo Infant SpO2 Adhesive Sensors, 18 in.
• 30817357020466: Masimo Pediatric SpO2 Adhesive Sensors, 18 in.
• 30817357020336: Masimo Neonatal SpO2 Adhesive Sensors, 3 ft.
• 30817357020183: Masimo Neonatal SpO2 Adhesive Sensors, 3 ft.
• 30817357020091: Masimo Neonatal SpO2 Adhesive Sensors, 18 in.
• 30817357020053: Masimo Adult SpO2 Adhesive Sensors, 18 in.