Thermogard™ Vest, S/M

Primary DI
00849111076128
Brand
Thermogard™ Vest, S/M
Company
Zoll Circulation, Inc.
Model
S/M
Catalog number
8700-000937-01
Device description
Thermogard™ Vest, S/M
Published
2024-05-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NZEHyperthermia Monitor

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NZEHyperthermia MonitorCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K231182000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K231182000Thermogard HQ™ Temperature Management System, Thermogard XP® Temperature Management SystemZoll Circulation, Inc.2023-11-03NZE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00849111076128PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00849111076128008491110761288491110761280849111076128

GMDN Terms#

Term, Definition table
TermDefinition
External circulating-fluid core temperature regulation system pad, single-useAn underlay, overlay, or wrap(s) through which temperature-regulated fluid is circulated, as part of an external circulating-fluid core temperature regulation system, intended to elevate and/or lower a patient’s core body temperature, typically in the operating room (OR), intensive care unit (ICU), or a recovery unit. The underlay/overlay is available in a variety of lengths, widths, and thicknesses to accommodate body size and application (e.g., adult/paediatric, full-/partial-body). It is intended to be used by a healthcare professional in a clinical setting. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
4085412140udisj@zoll.com

Regulatory Flags#

DUNS number
799455241
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00849111076296VitalTemp™ VitalTemp™ Universal Pad, 2PK, US8700-0011312025-12-12
10849111076293VitalTemp™ VitalTemp™ Universal Pad, 2PK, US8700-0011312025-12-12
00849111076074Thermogard HQ Surface Start-Up KitSurface Start-Up Kit8700-000935-012024-05-22
00849111076081ThermoGard XP Surface Start-Up KitSurface Start-Up Kit8700-000936-012024-05-22
00849111076135Thermogard™ Vest, L/XL L/XL8700-000938-012024-05-22
00849111076098STX SURFACE COOLING S/M PAD8700-000838-012024-08-15
00849111076104STX SURFACE COOLING L/XL PAD 8700-000839-012024-08-15
00849111076111STX SURFACE COOLINGTHIGHS ONLY PAD SET8700-000840-012024-08-15
00849111075787Thermogard XP, Lang set C, RohsThermogardHQ, Lang set C601337-0012023-01-17
00849111075794Thermogard XP, Lang set C, Rohs, RefurbThermogard XP, Lang set C, Rohs, Refurb2023-01-17
00849111075800Thermogard HQTM ConsoleThermogardHQ, Lang set A8700-001030-01 2022-06-27
00849111075862Thermogard HQTM Start-Up KitTG2-500D8700-001027-012022-06-27
00849111075879Thermogard HQTM Start-Up Kit EXTG2-500D, Extended Length8700-001028-012022-06-27
00849111050029Start-Up KitCG-500D8700-0666-032015-03-31
00849111050043ICY-3, Japan, Final Packaged Kit (Applause) IC-38938700-0657-032016-10-10
00849111050050Quattro, Japan, Final Packaged Kit (Applause) IC-45932016-10-10
00849111050074Cool Line® Intravascular Heat Exchange Catheter Kit (Applause)N/A8700-0654-032015-03-31
00849111050081Start-Up Kit JapanCG-500D8700-0785-032016-10-10
00849111075008Thermogard XP®Thermogard XP, Lang set B, Rohs2015-03-31
00849111075015Thermogard XP®Thermogard XP, Lang set A, Rohs2015-03-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00849111076296VitalTemp™ Zoll Circulation, Inc.NZE2025-12-12
10849111076293VitalTemp™ Zoll Circulation, Inc.NZE2025-12-12
00849111076074Thermogard HQ Surface Start-Up KitZoll Circulation, Inc.NZE2024-05-22
00849111076081ThermoGard XP Surface Start-Up KitZoll Circulation, Inc.NZE2024-05-22
00849111076135Thermogard™ Vest, L/XLZoll Circulation, Inc.NZE2024-05-22
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