Identity
- Trade Name
- iCOR FDA UDI
- Generic Name
- Heat/moisture exchanger, single-use FDA UDI
- Device Name
- BE FDA UDI
- Model / Reference
- IPN040460 FDA UDI
- Description
- BE FDA UDI
Identifiers
- Catalog Number
- 01-06-1980-8 FDA UDI
- Primary DI / UDI-DI
- 09555342303902 FDA UDI
- 510(k) Number
- K881308 FDA UDI
- FDA Product Code
- BYD FDA UDI
- GMDN Term
- Heat/moisture exchanger, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 868.5375 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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Heat/moisture exchanger, single-use
iCOR by Teleflex Incorporated — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K881308 also covers:
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 I | Pending data |
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Manufacturer
- Manufacturer
- Teleflex Incorporated
Sources (1)
- FDA UDI fe7b3cfc-33d7-44ea-af06-00594e043c42 36 fields · synced Jun 8, 2026