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Constavac CBC II

FDA UDI

Class II (US FDA UDI)

by 3T Medical Systems Inc.

Identity

Trade Name
Constavac CBC II FDA UDI
Generic Name
Whole-blood-recovery autotransfusion system, powered FDA UDI
Device Name
ConstaVac CBCII Blood Conservation Kit with 1/8” Round PVC Drain & Curved Trocar FDA UDI
Model / Reference
225-028-514 FDA UDI
Description
ConstaVac CBCII Blood Conservation Kit with 1/8” Round PVC Drain & Curved Trocar FDA UDI

Identifiers

Catalog Number
225-028-514 FDA UDI
Primary DI / UDI-DI
00855168008111 FDA UDI
510(k) Number
K970714 FDA UDI
FDA Product Code
CAC FDA UDI
GMDN Term
Whole-blood-recovery autotransfusion system, powered 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

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

Constavac CBC II by 3T Medical Systems Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K970714 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
3T Medical Systems Inc.

Sources (1)

  • FDA UDI 1f477b5f-8600-4d43-a784-7d879cf6120b 39 fields · synced Jun 8, 2026