NIGHTOWL

GUDID 09353645351022

NIGHTOWL USA

RESMED ASIA PTE. LTD.

Wearable multiple physiological parameter recorder, reusable

• Primary Device ID: 09353645351022
• NIH Device Record Key: eaa1684b-44e8-4bb2-9f4e-737b7b5cb162
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NIGHTOWL
• Version Model Number: 35102
• Company DUNS: 659298251
• Company Name: RESMED ASIA PTE. LTD.
• 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: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	09353645351022 [Primary]

FDA Product Code

• MNR: Ventilatory Effort Recorder

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-08-12
• Device Publish Date: 2025-08-04

Devices Manufactured by RESMED ASIA PTE. LTD.

• 09353645351022 - NIGHTOWL: 2025-08-12NIGHTOWL USA
• 09353645351022 - NIGHTOWL: 2025-08-12 NIGHTOWL USA
• 09353645610303 - Pixi Pediatric Mask: 2025-05-08 Pixi Pediatric Mask - AMER
• 09353645401048 - Oxyensure Mounting Straps: 2023-07-31 Oxyensure POC Mounting Straps (AMO)
• 09353645350520 - External Battery Assembly: 2023-04-04 Mobi External Battery
• 09353645000098 - Charger AC/DC with power cord: 2021-07-22 Activox, Charger AC/DC with power cord
• 09353645350537 - AC/DC Charger US: 2021-07-22 AC/DC Charger US (AMO)
• 09353645401062 - Oxyensure AC/DC Charger US: 2021-07-22 Oxyensure POC AC/DC Charger US (AMO)
• 09353645000562 - Mobi: 2021-01-18 Mobi - Refurbished