SpO2 Sensor

GUDID 06944413805385

Edan Instruments, Inc.

Pulse oximeter probe, reusable

• Primary Device ID: 06944413805385
• NIH Device Record Key: 31aaf28a-28ac-4c05-a315-60636ec8f6c4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SpO2 Sensor
• Version Model Number: SH5 pediatric Silicone Soft-tip
• Company DUNS: 529173163
• Company Name: Edan Instruments, Inc.
• Device Count: 1
• DM Exempt: false
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06944413805385 [Primary]

FDA Product Code

• DQA: Oximeter

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-01

On-Brand Devices [SpO2 Sensor]

• 06944413807129: SH6, Ear Clip, Adult/Pediatric, 1m, reusable
• 06944413805439: SHD-A , adult, disposable
• 06944413805422: SHD-P, pediatric, disposable
• 06944413805415: SHD-I , Infant, disposable
• 06944413805408: SHD-N, Neonate, disposable
• 06944413805385: SH5 pediatric Silicone Soft-tip
• 06944413805378: SpO2 Silicone Soft-tip Sensor,pediatric，1m，reusabl
• 06944413805361: SH4 Adult Silicone Soft-tip
• 06944413805354: SpO2 Silicone Soft-tip Sensor,adult,1m, reusable
• 06944413805347: SpO2 Sensor, Wrap, Neonate, 1m, reusable
• 06944413805323: SpO2 Finger Sensor, adult, 1m, reusable
• 06944413805309: SpO2 Finger Sensor, adult, 2.5m, reusable
• 06944413810846: SH1
• 06944413812055: 02.57.225039