Identity
- Trade Name
- Start-Up Kit Extended Length, Custom Luer FDA UDI
- Generic Name
- Intravascular core temperature regulation system start kit FDA UDI
- Device Name
- 9 foot tubing set including integral air trap chamber and stainless steel heat exchange coil FDA UDI
- Model / Reference
- CG-500D EX FDA UDI
- Description
- 9 foot tubing set including integral air trap chamber and stainless steel heat exchange coil FDA UDI
Identifiers
- Catalog Number
- 8700-0785-01 FDA UDI
- Primary DI / UDI-DI
- 00849111075350 FDA UDI
- 510(k) Number
- K014241 FDA UDI
- FDA Product Code
- NCX FDA UDI
- GMDN Term
- Intravascular core temperature regulation system start kit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.5900 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Safe FDA UDI
Dimensions & Sizes
- Size
- Length — 9 Feet FDA UDI
Category: Intravascular core temperature regulation system start kit
Start-Up Kit Extended Length, Custom Luer by ZOLL Circulation, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Intravascular core temperature regulation system start kit.
- Thermogard HQTM Start-Up Kit EX — ZOLL Circulation, Inc. · Class II
- Start-Up Kit Japan — ZOLL Circulation, Inc. · Class II
- Thermogard HQTM Start-Up Kit — ZOLL Circulation, Inc. · Class II
- Start-Up Kit Custom Luer — ZOLL Circulation, Inc. · Class II
- Start-Up Kit — ZOLL Circulation, Inc. · Class II
- Start-Up Kit — ZOLL Circulation, Inc. · Class II
- Start-Up Kit Extended Length — ZOLL Circulation, Inc. · Class II
Cleared under the same submission
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- ZOLL Circulation, Inc.
Sources (1)
- FDA UDI 69505a21-5a01-49e4-a457-355c2fcd9be1 38 fields · synced Jun 9, 2026