Neonatal Starter Set (without Service Gas)

GUDID 07640121880445

Neonatal Starter Set (without Service Gas) contains: Multi-Site Attachment Rings for mature/intact skin (MAR-MI) Multi-Site Attachment Rings for sensi

SenTec AG

Transcutaneous blood gas monitoring system Transcutaneous blood gas monitoring system Transcutaneous blood gas monitoring system Transcutaneous blood gas monitoring system Transcutaneous blood gas monitoring system Transcutaneous blood gas monitoring system Transcutaneous blood gas monitoring system Transcutaneous blood gas monitoring system Transcutaneous blood gas monitoring system Transcutaneous blood gas monitoring system Transcutaneous blood gas monitoring system Transcutaneous blood gas monitoring system Transcutaneous blood gas monitoring system Transcutaneous blood gas monitoring system Transcutaneous blood gas monitoring system Transcutaneous blood gas monitoring system Transcutaneous blood gas monitoring system Transcutaneous blood gas monitoring system

• Primary Device ID: 07640121880445
• NIH Device Record Key: 2b1bdfd2-c7bc-47e9-84c0-ae6e62f6f75c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Neonatal Starter Set (without Service Gas)
• Version Model Number: SSET-N_nG
• Company DUNS: 480797856
• Company Name: SenTec AG
• 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: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *during transport: 0-50°C
• Storage Environment Humidity: Between 25 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *during transport: 0-50°C
• Storage Environment Humidity: Between 25 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *during transport: 0-50°C
• Storage Environment Humidity: Between 25 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *during transport: 0-50°C
• Storage Environment Humidity: Between 25 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *during transport: 0-50°C
• Storage Environment Humidity: Between 25 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *during transport: 0-50°C
• Storage Environment Humidity: Between 25 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *during transport: 0-50°C
• Storage Environment Humidity: Between 25 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *during transport: 0-50°C
• Storage Environment Humidity: Between 25 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *during transport: 0-50°C
• Storage Environment Humidity: Between 25 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *during transport: 0-50°C
• Storage Environment Humidity: Between 25 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *during transport: 0-50°C
• Storage Environment Humidity: Between 25 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *during transport: 0-50°C
• Storage Environment Humidity: Between 25 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *during transport: 0-50°C
• Storage Environment Humidity: Between 25 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *during transport: 0-50°C
• Storage Environment Humidity: Between 25 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *during transport: 0-50°C
• Storage Environment Humidity: Between 25 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *during transport: 0-50°C
• Storage Environment Humidity: Between 25 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *during transport: 0-50°C
• Storage Environment Humidity: Between 25 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *during transport: 0-50°C
• Storage Environment Humidity: Between 25 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	07640121880445 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K041548

FDA Product Code

• DPZ: Oximeter, Ear

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-08-31

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