Masimo

GUDID 30817357020091

Masimo Neonatal SpO2 Adhesive Sensors, 18 in.

HYGIA HEALTH SERVICES, INC.

Pulse oximeter probe, reprocessed

• Primary Device ID: 30817357020091
• NIH Device Record Key: 5a6e4dd4-41a9-4039-97d5-d61c607de418
• Commercial Distribution Discontinuation: 2019-07-31
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Masimo
• Version Model Number: 2329
• 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	10817357020097 [Primary]
GS1	30817357020091 [Package]; Contains: 10817357020097; 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.