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Haemonetics Cell Saver 5/5+ System

FDA UDI

Class II (US FDA UDI)

by Haemonetics Corporation

Identity

Trade Name
HAEMONETICS CELL SAVER 5/5+ SYSTEM FDA UDI
Generic Name
Autotransfusion system blood component processing set FDA UDI
Device Name
CS5/5+ FASTPACK,225ML, 20µ RES FDA UDI
Model / Reference
0260F-00 FDA UDI
Description
CS5/5+ FASTPACK,225ML, 20µ RES FDA UDI

Identifiers

Primary DI / UDI-DI
10812747016261 FDA UDI
510(k) Number
K932890 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
Not 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

Yes

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

Dimensions & Sizes

Size
Total Volume — 225 Milliliter FDA UDI
Pore Size — 20 Micrometer FDA UDI

Haemonetics Cell Saver 5/5+ System by Haemonetics Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K932890 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 2d0d8c2a-d59a-481c-a5a5-37291be8b1d8 37 fields · synced Jun 8, 2026