Beddr

GUDID 00857796008013

Beddr

Pulse oximeter, battery-powered

• Primary Device ID: 00857796008013
• NIH Device Record Key: 1584ba9c-e547-48ce-8ae0-321e313ac43d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Beddr
• Version Model Number: SleepTuner
• Company DUNS: 832721539
• Company Name: Beddr
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• 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: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00857796008013 [Primary]

FDA Product Code

• PGJ: Oximeter, Wellness

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: 2018-11-22
• Device Publish Date: 2018-10-22

On-Brand Devices [Beddr]

• 00857796008020: Adhesives
• 00857796008013: SleepTuner