Identity
- Trade Name
- Procure FDA UDI
- Generic Name
- Heat/moisture exchanger, single-use FDA UDI
- Device Name
- HMEF Adult In-Line Maxi HMEF W/out Port 350 - 1500 ML VT Range 49.15 ml Dead Space FDA UDI
- Model / Reference
- 010-105564 FDA UDI
- Description
- HMEF Adult In-Line Maxi HMEF W/out Port 350 - 1500 ML VT Range 49.15 ml Dead Space FDA UDI
Identifiers
- Catalog Number
- 010-105564 FDA UDI
- Primary DI / UDI-DI
- 10840330700235 FDA UDI
- 510(k) Number
- K922492 FDA UDI
- FDA Product Code
- CAH FDA UDI
- GMDN Term
- Heat/moisture exchanger, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5260 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Heat/moisture exchanger, single-use
Procure by Twin Med, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K922492 also covers:
- CARDINAL HEALTH — Cardinal Health 200, LLC
- CARDINAL HEALTH — Cardinal Health 200, LLC
- CARDINAL HEALTH — Cardinal Health 200, LLC
- CARDINAL HEALTH — Cardinal Health 200, LLC
- CARDINAL HEALTH — Cardinal Health 200, LLC
- CARDINAL HEALTH — Cardinal Health 200, LLC
- CARDINAL HEALTH — Cardinal Health 200, LLC
- CARDINAL HEALTH — Cardinal Health 200, LLC
- CARDINAL HEALTH — Cardinal Health 200, LLC
- CARDINAL HEALTH — Cardinal Health 200, LLC
- CARDINAL HEALTH — Cardinal Health 200, LLC
- CARDINAL HEALTH — Cardinal Health 200, LLC
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
- Twin Med, LLC
Sources (1)
- FDA UDI f8e3929f-7f76-4d61-9c7a-16bf5f02098a 36 fields · synced May 30, 2026