MED2926

GUDID 00851962007640

30" width single cavity zone heating blanket and fluid warmer, 24" depth

ENTHERMICS, INC.

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 Multi-purpose warming cabinet, stationary

• Primary Device ID: 00851962007640
• NIH Device Record Key: 8448cbac-f5b2-4810-a3a3-787c5d56b0a4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MED2926
• Version Model Number: MED2926
• 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	00851962007640 [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: 2021-06-04
• Device Publish Date: 2021-05-27

Devices Manufactured by ENTHERMICS, INC.

• 00851962007695 - EC1540: 2022-07-11 15.4 cu ft irrigation fluid warmer
• 00851962007701 - MED3373: 2022-07-11 15.4 cu ft irrigation fluid warmer
• 00851962007718 - P-2040: 2022-07-11 15.4 cu ft irrigation fluid warmer
• 00851962007572 - MEDIVNOW: 2021-06-04 modular fluid warmer
• 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: 2021-06-0430" width single cavity zone heating blanket and fluid warmer, 24" depth
• 00851962007640 - MED2926: 2021-06-04 30" width single cavity zone heating blanket and fluid warmer, 24" depth