Panda

GUDID 00840682103893

DATEX-OHMEDA INC

Infant warmer

• Primary Device ID: 00840682103893
• NIH Device Record Key: d4ed1c50-ac67-40cc-9b91-909238d8b8e0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Panda
• Version Model Number: iRes Warmer
• Company DUNS: 080887689
• Company Name: DATEX-OHMEDA 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: false
• 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

• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840682103893 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K123309

FDA Product Code

• FMT: WARMER, INFANT RADIANT

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-10-15
• Device Publish Date: 2016-06-24

On-Brand Devices [Panda]

• 00840682103916: Freestanding Warmer
• 00840682103909: Wall Mount Warmer
• 00840682103893: iRes Warmer