ThermoTrace Core (5pcs)

GUDID 04048675428916

Drägerwerk AG & Co. KGaA

General-purpose patient temperature probe, single-use

• Primary Device ID: 04048675428916
• NIH Device Record Key: 54a82841-7b67-451a-8afb-2528a1a41c31
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ThermoTrace Core (5pcs)
• Version Model Number: MX11000
• Company DUNS: 315578914
• Company Name: Drägerwerk AG & Co. KGaA
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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

Customer Support Contacts

• Phone: +494518820
• Email: info@draeger.com
• Phone: +494518820
• Email: info@draeger.com
• Phone: +494518820
• Email: info@draeger.com
• Phone: +494518820
• Email: info@draeger.com
• Phone: +494518820
• Email: info@draeger.com
• Phone: +494518820
• Email: info@draeger.com
• Phone: +494518820
• Email: info@draeger.com
• Phone: +494518820
• Email: info@draeger.com
• Phone: +494518820
• Email: info@draeger.com
• Phone: +494518820
• Email: info@draeger.com
• Phone: +494518820
• Email: info@draeger.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	04048675000327 [Package]; Package: [5 Units]; In Commercial Distribution
GS1	04048675428916 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K971198

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: 2025-09-09
• Device Publish Date: 2015-10-24

Devices Manufactured by Drägerwerk AG & Co. KGaA

• 04048675428909 - ThermoTrace_Peripheral_5pcs: 2025-09-09
• 04048675428916 - ThermoTrace Core (5pcs): 2025-09-09
• 04048675428916 - ThermoTrace Core (5pcs): 2025-09-09
• 04048675695622 - Anesthesia Circuit Kit Coax HEPA: 2025-05-27
• 04048675695639 - Anesthesia Circuit Kit Flex HEPA: 2025-05-27
• 04048675686729 - VentStar Resus heated (N): 2025-05-22
• 04048675686743 - VentStar AutoBreath heated (N): 2025-05-22
• 04048675125525 - CLIC adapter: 2025-05-02
• 04048675379317 - ECG trunk cable,3-lead,Neo: 2025-04-18