Identity
- Trade Name
- PXL 8 FDA UDI
- Generic Name
- Blood transfusion filter FDA UDI
- Device Name
- PXL 8 High Efficiency Leukocyte Reduction Filter for Platelets with Attached Y-Type Administration Set FDA UDI
- Model / Reference
- PXL8Y FDA UDI
- Description
- PXL 8 High Efficiency Leukocyte Reduction Filter for Platelets with Attached Y-Type Administration Set FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10887691000550 FDA UDI
- 510(k) Number
- K873667 FDA UDI
- FDA Product Code
- CAK FDA UDI
- GMDN Term
- Blood transfusion filter FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5440 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: Blood transfusion filter
Pxl 8 by Haemonetics Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Blood transfusion filter.
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- NeoDevices, Inc. — NEODEVICES INC · Class II
- HEMO-NATE — Utah Medical Products, Inc. · Class II
- HEMO-NATE — Utah Medical Products, Inc. · Class II
- HEMO-TAP — Utah Medical Products, Inc. · Class II
- HEMO-NATE — Utah Medical Products, Inc. · Class II
Cleared under the same submission
K873667 also covers:
- Haemonetics — HAEMONETICS CORPORATION
- Haemonetics — HAEMONETICS CORPORATION
- Haemonetics — HAEMONETICS CORPORATION
- Haemonetics — HAEMONETICS CORPORATION
- Haemonetics — HAEMONETICS CORPORATION
- PL High Efficiency Leukocyte Reduction Filter — HAEMONETICS CORPORATION
- PXL 12 High Efficiency Leukocyte Reduction Filter — HAEMONETICS CORPORATION
- PXL 12 High Efficiency Leukocyte Reduction Filter for Platelets — HAEMONETICS CORPORATION
- PXL 8 — HAEMONETICS CORPORATION
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
- Haemonetics Corporation
Sources (1)
- FDA UDI 6818472e-b6cd-452c-a673-e83a7e7da343 35 fields · synced Jun 8, 2026