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Haemonetics Smartsuction Technology

FDA UDI

Class II (US FDA UDI)

by Haemonetics Corporation

Identity

Trade Name
HAEMONETICS SMARTSUCTION TECHNOLOGY FDA UDI
Generic Name
Autotransfusion system blood component processing set FDA UDI
Device Name
VACUUM LINE, FILTERED FDA UDI
Model / Reference
HAR-A-1000 FDA UDI
Description
VACUUM LINE, FILTERED FDA UDI

Identifiers

Primary DI / UDI-DI
10812747017336 FDA UDI
510(k) Number
K052626 FDA UDI
FDA Product Code
BTA FDA UDI
GMDN Term
Autotransfusion system blood component processing set FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.4780 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: Autotransfusion system blood component processing set

Haemonetics Smartsuction Technology by Haemonetics Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Autotransfusion system blood component processing set.

Cleared under the same submission

K052626 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 272205f5-2030-40b9-8cb7-4d4e344b8615 35 fields · synced Jun 8, 2026