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ECC Large Pack

FDA UDI

Class II (US FDA UDI)

by Datascope Corp.

Identity

Trade Name
ECC Large Pack FDA UDI
Generic Name
Cardiopulmonary bypass system blood tubing set FDA UDI
Device Name
BEQ-HMOD 70000-USA Adult Quadrox iD, Blood Transfer Bag 1000ml - 2 spike ports, Gas Filter FDA UDI
Model / Reference
BEQ-TOP 5221 FDA UDI
Description
BEQ-HMOD 70000-USA Adult Quadrox iD, Blood Transfer Bag 1000ml - 2 spike ports, Gas Filter FDA UDI

Identifiers

Catalog Number
709000570R01 FDA UDI
Primary DI / UDI-DI
00607567213234 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

ECC Large Pack 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 9701508b-2731-4a49-96f8-3b32cb6a659f 36 fields · synced May 31, 2026