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Lvad/ 3/8"

FDA UDI

Class II (US FDA UDI)

by Datascope Corp.

Identity

Trade Name
LVAD/ 3/8" FDA UDI
Generic Name
Cardiopulmonary bypass system blood tubing set FDA UDI
Device Name
Softshell Venous Reser. 800ml, BEQ-RF32 RotaFlow, CDI Sat Cell 3/8" System 100, Blood Microfilter System SQ 40 S, Gas Filter FDA UDI
Model / Reference
BEQ-T 3501 FDA UDI
Description
Softshell Venous Reser. 800ml, BEQ-RF32 RotaFlow, CDI Sat Cell 3/8" System 100, Blood Microfilter System SQ 40 S, Gas Filter FDA UDI

Identifiers

Catalog Number
701068008R02 FDA UDI
Primary DI / UDI-DI
00607567212862 FDA UDI
FDA Product Code
DWE FDA UDI
GMDN Term
Cardiopulmonary bypass system blood tubing set FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.4390 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

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

Yes

FDA UDI
Sterilization Method
Ethylene Oxide FDA UDI

Category: Cardiopulmonary bypass system blood tubing set

Lvad/ 3/8" by Datascope Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cardiopulmonary bypass system blood tubing set.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Datascope Corp.

Sources (1)

  • FDA UDI a57bc0d6-219d-4448-9bb1-b5f15d0840c4 36 fields · synced May 30, 2026