HypothermX HX100 Intravenous Fluid and Blood Warmer

GUDID 00850003277035

EMIT CORPORATION

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 Conduction blood/fluid warmer Conduction blood/fluid warmer

• Primary Device ID: 00850003277035
• NIH Device Record Key: fff3fa36-7042-4522-8656-128908421599
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HypothermX HX100 Intravenous Fluid and Blood Warmer
• Version Model Number: FA100001
• Company DUNS: 958227451
• Company Name: EMIT CORPORATION
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850003277004 [Primary]
GS1	00850003277011 [Package]; Contains: 00850003277004; Package: 5 Pack [5 Units]; In Commercial Distribution
GS1	00850003277028 [Package]; Contains: 00850003277004; Package: Single Pack [1 Units]; In Commercial Distribution
GS1	00850003277035 [Package]; Contains: 00850003277004; Package: 2 Pack [2 Units]; In Commercial Distribution
GS1	00850003277103 [Package]; Contains: 00850003277004; Package: 3 Pack [3 Units]; In Commercial Distribution
GS1	00850003277110 [Package]; Contains: 00850003277004; Package: 4 Pack [4 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K103801

FDA Product Code

• LGZ: Warmer, Thermal, Infusion Fluid

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-11-26
• Device Publish Date: 2018-10-25

Devices Manufactured by EMIT CORPORATION

• 00850003277035 - HypothermX HX100 Intravenous Fluid and Blood Warmer: 2018-11-26
• 00850003277035 - HypothermX HX100 Intravenous Fluid and Blood Warmer: 2018-11-26
• 00850003277042 - HypothermX LG Intravenous Fluid and Blood Warmer: 2018-11-26