Identity
- Trade Name
- Orthofuser FDA UDI
- Generic Name
- Autotransfusion system blood component processing set FDA UDI
- Model / Reference
- Drain Line FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00803622132155 FDA UDI
- 510(k) Number
- K912019 FDA UDI
- FDA Product Code
- CAC FDA UDI
- GMDN Term
- Autotransfusion system blood component processing set FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5830 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: Autotransfusion system blood component processing set
Orthofuser by LivaNova USA, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Autotransfusion system blood component processing set.
- AUTOTRANSFUSION ACCESSORIES — SORIN GROUP ITALIA SRL · Class II
- autoLog® — MEDTRONIC, INC. · Class II
- HAEMONETICS PCS 2 APHERESIS SYSTEM — HAEMONETICS CORPORATION · Class II
- XTRA — SORIN GROUP ITALIA SRL · Class II
- PREASSEMBLED SURGICAL WASH SET — SORIN GROUP ITALIA SRL · Class II
- ATF 40 Fast start kit with AT3 — Fresenius Kabi · Class II
- HAEMONETICS PCS 2 APHERESIS SYSTEM — HAEMONETICS CORPORATION · Class II
- HAEMONETICS CELL SAVER ELITE SYSTEM — HAEMONETICS CORPORATION · Class II
Cleared under the same submission
K912019 also covers:
- Drain Line — LivaNova USA, Inc.
- Orthofuser — LivaNova USA, Inc.
- Orthofuser — LivaNova USA, Inc.
- Orthofuser — LivaNova USA, Inc.
- Orthofuser — LivaNova USA, Inc.
- Orthofuser — LivaNova USA, Inc.
- Orthofuser — LivaNova USA, Inc.
- Orthofuser — LivaNova USA, Inc.
- Orthofuser — LivaNova USA, Inc.
- Orthofuser — LivaNova USA, 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- LivaNova USA, Inc.
Sources (1)
- FDA UDI e57739ba-e261-42f2-95fa-d71806610071 33 fields · synced Jun 8, 2026