Thermogard™ Vest, L/XL 8700-000938-01

GUDID 00849111076135

Thermogard™ Vest, L/XL

Zoll Circulation, Inc.

External circulating-fluid core temperature regulation system pad, single-use

• Primary Device ID: 00849111076135
• NIH Device Record Key: 3f482143-9aa2-4318-9a8d-804f9f7c369f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Thermogard™ Vest, L/XL
• Version Model Number: L/XL
• Catalog Number: 8700-000938-01
• Company DUNS: 799455241
• Company Name: Zoll Circulation, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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

Customer Support Contacts

• Phone: 4085412140
• Email: udisj@zoll.com
• Phone: 4085412140
• Email: udisj@zoll.com
• Phone: 4085412140
• Email: udisj@zoll.com
• Phone: 4085412140
• Email: udisj@zoll.com
• Phone: 4085412140
• Email: udisj@zoll.com
• Phone: 4085412140
• Email: udisj@zoll.com
• Phone: 4085412140
• Email: udisj@zoll.com
• Phone: 4085412140
• Email: udisj@zoll.com
• Phone: 4085412140
• Email: udisj@zoll.com
• Phone: 4085412140
• Email: udisj@zoll.com
• Phone: 4085412140
• Email: udisj@zoll.com
• Phone: 4085412140
• Email: udisj@zoll.com
• Phone: 4085412140
• Email: udisj@zoll.com
• Phone: 4085412140
• Email: udisj@zoll.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00849111076135 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K231182

FDA Product Code

• NZE: Hyperthermia Monitor

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: 2024-05-30
• Device Publish Date: 2024-05-22

Devices Manufactured by Zoll Circulation, Inc.

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• 00849111076111 - STX SURFACE COOLING: 2024-08-23 STX SURFACE COOLING Pad THIGHS ONLY PAD SET
• 00849111076074 - Thermogard HQ Surface Start-Up Kit: 2024-05-30 The Surface Start-Up Kit is a tubing set that connects the Thermogard XP® console to a STx™ Vest or Thermogard™ Vest surfac
• 00849111076081 - ThermoGard XP Surface Start-Up Kit: 2024-05-30 The Surface Start-Up Kit is a tubing set that connects the Thermogard XP® console to a STx™ Vest or Thermogard™ Vest surfac
• 00849111076128 - Thermogard™ Vest, S/M: 2024-05-30 Thermogard™ Vest, S/M
• 00849111076135 - Thermogard™ Vest, L/XL: 2024-05-30Thermogard™ Vest, L/XL
• 00849111076135 - Thermogard™ Vest, L/XL: 2024-05-30 Thermogard™ Vest, L/XL
• 00849111075787 - Thermogard XP, Lang set C, Rohs: 2023-12-18 The THERMOGARD is an integrated electro-mechanical heater/cooler that consists of a temperature monitor, a temperature controlle