Panda

GUDID 00840682152709

Panda iRes Warmer V1.0

Datex-Ohmeda, Inc.

Infant warmer

• Primary Device ID: 00840682152709
• NIH Device Record Key: 8c49c74f-6ca8-45cc-acfb-e40856aa308b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Panda
• Version Model Number: i-Res Warmer 1.0
• Company DUNS: 118933716
• 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

Customer Support Contacts

• Phone: +1(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840682152709 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K122267

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: 2
• Public Version Date: 2025-12-08
• Device Publish Date: 2020-06-11

Devices Manufactured by Datex-Ohmeda, Inc.

• 00840682152709 - Panda: 2025-12-08Panda iRes Warmer V1.0
• 00840682152709 - Panda: 2025-12-08 Panda iRes Warmer V1.0
• 05060433670091 - NOVII INTERFACE CABLE: 2025-05-06 NOVII INTERFACE CABLE - GE FECG
• 05060433670114 - NOVII INTERFACE CABLE: 2025-05-06 Monica Interface CTG Cable - GE Corometrics MECG round green connector
• 05060433670138 - NOVII INTERFACE CABLE: 2025-05-06 NOVII INTERFACE CABLE - GE UA
• 15060433670074 - Novii: 2025-05-02 Novii Patch