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Circulatory ECC

FDA UDI

Class II (US FDA UDI)

by Datascope Corp.

Identity

Trade Name
Circulatory ECC FDA UDI
Generic Name
Cardiopulmonary bypass system blood tubing set FDA UDI
Device Name
BEW HMOD 70000 BEQ RF32 BMY CEll Arterial Sensor Gas Filter FDA UDI
Model / Reference
BEQ T 5502 FDA UDI
Description
BEW HMOD 70000 BEQ RF32 BMY CEll Arterial Sensor Gas Filter FDA UDI

Identifiers

Catalog Number
701051791 FDA UDI
Primary DI / UDI-DI
00607567202016 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

Yes

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

Circulatory ECC 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 fac4e770-a4c6-4cb3-9faf-266174904a9c 36 fields · synced May 29, 2026