ivNext

GUDID 00851962007435

2.5 cu ft zone heating fluid warmer

ENTHERMICS, INC.

Conduction blood/fluid warmer Conduction blood/fluid warmer Conduction blood/fluid warmer Conduction blood/fluid warmer Conduction blood/fluid warmer Conduction blood/fluid warmer Conduction blood/fluid warmer Conduction blood/fluid warmer Conduction blood/fluid warmer Conduction blood/fluid warmer Conduction blood/fluid warmer Conduction blood/fluid warmer Multi-purpose warming cabinet, stationary Multi-purpose warming cabinet, stationary Multi-purpose warming cabinet, stationary Multi-purpose warming cabinet, stationary Multi-purpose warming cabinet, stationary Multi-purpose warming cabinet, stationary Multi-purpose warming cabinet, stationary Multi-purpose warming cabinet, stationary Multi-purpose warming cabinet, stationary Multi-purpose warming cabinet, stationary Multi-purpose warming cabinet, stationary Multi-purpose warming cabinet, stationary Multi-purpose warming cabinet, stationary Multi-purpose warming cabinet, stationary Multi-purpose warming cabinet, stationary

• Primary Device ID: 00851962007435
• NIH Device Record Key: b3a3a617-150c-4864-9d12-187b22eb93cb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ivNext
• Version Model Number: ivNext
• Company DUNS: 139782767
• Company Name: ENTHERMICS, 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00851962007435 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132202

FDA Product Code

• LGZ: Warmer, Thermal, Infusion Fluid

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: 2020-07-24
• Device Publish Date: 2020-07-16

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• 00851962007619 - MED2422-L: 2021-06-04 2.5 cu ft zone heating fluid warmer
• 00851962007626 - MED2428-L: 2021-06-04 3.5 cu ft zone heating fluid warmer
• 00851962007633 - MED2226: 2021-06-04 30" width single cavity zone heating blanket and fluid warmer, 18" depth
• 00851962007640 - MED2926: 2021-06-04 30" width single cavity zone heating blanket and fluid warmer, 24" depth