FDA UDI
In Commercial Distribution
🇺🇸 United States
ThermoGard XP Surface Start-Up Kit
DI: 00849111076081
·
Model: Surface Start-Up Kit
·
Zoll Circulation, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- ThermoGard XP Surface Start-Up Kit
- Primary DI
- 00849111076081
- Version / Model
- Surface Start-Up Kit
- Catalog Number
- 8700-000936-01
- Company Name
- Zoll Circulation, Inc.
- Labeler DUNS
- 799455241
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-05-22
- Public Version
- 2
- Public Version Date
- 2025-12-01
- Public Version Status
- Update
- Public Device Record Key
- 62b98002-79fc-417b-bbf4-87be20716df3
Device Description
The Surface Start-Up Kit is a tubing set that connects the Thermogard XP® console to a STx™ Vest or Thermogard™ Vest surface pad. The Surface Start-Up Kit is a closed-loop disposable that is composed of a pre-attached water reservoir, an extension tubing, a pump loop, a heat exchange coil and an air trap assembly. All of these items work with the console to supply cool water to the surface pad to regulate patient core temperature.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Safe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| NZE | Hyperthermia Monitor | Cardiovascular | 870.5900 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 67029 | External circulating-fluid core temperature regulation system start kit | A collection of consumable devices intended to be used to facilitate the function of an external circulating-fluid core temperature regulation system. It typically includes tubing to connect the pump mechanism of the system control unit to a patient pad, a heat exchange coil, and other necessary components (e.g., water reservoir, air trap, flow indicator). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00849111076081 | GS1 |
Customer Contacts
- Phone
- 4085412140
- [email protected]