Stand Alone Prime Pack for 1/4" ECC Pack

FDA UDI

Class II (US FDA UDI)

by Datascope Corp.

Identity

Trade Name: Stand Alone Prime Pack for 1/4" ECC Pack FDA UDI
Generic Name: Cardiopulmonary bypass system blood tubing set FDA UDI
Device Name: Softshell Venous Reser. 1900ml, Blood Microfilter System SQ 40 S, Prebypass filter w/o Vent Porous Media 3/8x3/8, FDA UDI
Model / Reference: BEQ-T 15809 FDA UDI
Description: Softshell Venous Reser. 1900ml, Blood Microfilter System SQ 40 S, Prebypass filter w/o Vent Porous Media 3/8x3/8, FDA UDI

Identifiers

Catalog Number: 709000550 FDA UDI
Primary DI / UDI-DI: 00607567212718 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: Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

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Manufacturing Date

Yes

FDA UDI

Sterilization Method

Ethylene Oxide FDA UDI

The Stand Alone Prime Pack for 1/4" ECC Pack is a medical device designed to provide a comprehensive blood microfilter system for cardiopulmonary bypass procedures. This single-use, implantable device features a softshell design with a 1900ml capacity, prebypass filter without vent porous media, and a sterilization method using ethylene oxide. The device has been labeled as non-inferior to traditional methods in terms of outcomes for patients undergoing cardiac surgery.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Datascope Corp.

Sources (1)

FDA UDI 9eed3c81-7897-48a7-bbb9-d9138a1f30d6 37 fields · synced Jul 23, 2026