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Haemonetics Cell Saver Elite+ System

FDA UDI

Class II (US FDA UDI)

by Haemonetics Corporation

Identity

Trade Name
HAEMONETICS CELL SAVER ELITE+ SYSTEM FDA UDI
Generic Name
Autotransfusion system blood collection/processing pump FDA UDI
Device Name
CELL SAVER ELITE+ FDA UDI
Model / Reference
CSE-EW-US FDA UDI
Description
CELL SAVER ELITE+ FDA UDI

Identifiers

Primary DI / UDI-DI
30812747016364 FDA UDI
510(k) Number
K162423 FDA UDI
K221722 FDA UDI
FDA Product Code
CAC FDA UDI
GMDN Term
Autotransfusion system blood collection/processing pump 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

No

FDA UDI

Single Use

No

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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Autotransfusion system blood collection/processing pump

Haemonetics Cell Saver Elite+ System by Haemonetics Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Autotransfusion system blood collection/processing pump.

Cleared under the same submission

K221722 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Haemonetics Corporation

Sources (1)

  • FDA UDI ffb63115-e370-4443-83bb-2f7ec12c7b98 35 fields · synced Jun 8, 2026