Identity
- Trade Name
- Adult Heart Cooling Jacket FDA UDI
- Generic Name
- Cardiac arrest hypothermia kit FDA UDI
- Device Name
- The Heart Cooling Jacket is effective in controlling the temperature of the cardiac organ during an open heart surgery. The closed loop heat transfer system works to protect the cardiac organ. FDA UDI
- Model / Reference
- 2.4 FDA UDI
- Description
- The Heart Cooling Jacket is effective in controlling the temperature of the cardiac organ during an open heart surgery. The closed loop heat transfer system works to protect the cardiac organ. FDA UDI
Identifiers
- Catalog Number
- 17-260 FDA UDI
- Primary DI / UDI-DI
- 36641670001314 FDA UDI
- 510(k) Number
- K833112 FDA UDI
- FDA Product Code
- DWF FDA UDI
- GMDN Term
- Cardiac arrest hypothermia kit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.4210 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
Category: Cardiac arrest hypothermia kit
Adult Heart Cooling Jacket by Cardio Med Supplies, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Cardiac arrest hypothermia kit.
Cleared under the same submission
K833112 also covers:
- 1/2'' Y Connector w/L.L. — Cardio Med Supplies, Inc.
- 1/2'' x 1/2'' Straight Connector — Cardio Med Supplies, Inc.
- 1/2'' x 1/2'' Straight Connector w/L.L. — Cardio Med Supplies, Inc.
- 1/2'' x 3/8'' Reducer Connector — Cardio Med Supplies, Inc.
- 1/2'' x 3/8'' Reducer Connector w/L.L. — Cardio Med Supplies, Inc.
- 1/2'' x 3/8'' x 1/2'' Y Connector — Cardio Med Supplies, Inc.
- 1/2'' x 3/8'' x 3/8'' Y Connector — Cardio Med Supplies, Inc.
- 1/2'' x 3/8'' x 3/8'' Y Connector w/L.L. — Cardio Med Supplies, Inc.
- 1/2'' x 3/8'' x1/2'' Y Connector w/L.L. — Cardio Med Supplies, Inc.
- 1/4'' Tubing Adapter with Rotating Luer Lock — Cardio Med Supplies, Inc.
- 1/4'' Y Connector w/L.L. — Cardio Med Supplies, Inc.
- 1/4'' to I.V. Connector — Cardio Med Supplies, Inc.
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
- Cardio Med Supplies, Inc.
Sources (1)
- FDA UDI 90125c0d-ea71-4e19-9993-f4b567b7e090 35 fields · synced Jun 8, 2026