Teledyne

GUDID 00852470008136

Teledyne Analytical Instrs

Respiratory oxygen sensor

• Primary Device ID: 00852470008136
• NIH Device Record Key: 7d1f4a49-ad6d-4ef9-816c-cb8ca2d88c5c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Teledyne
• Version Model Number: R29IMED
• Company DUNS: 078344505
• Company Name: Teledyne Analytical Instrs
• 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: 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	00852470008136 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K001095

FDA Product Code

• CCL: Analyzer, Gas, Oxygen, Gaseous-Phase

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: 2019-09-06
• Device Publish Date: 2019-08-29

On-Brand Devices [Teledyne]

• 00852470008143: Oxygen Sensor
• 00852470008136: R29IMED
• 00852470008129: Oxygen Sensor