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Ochsner Small Pediatric ECC Pack

FDA UDI

Class II (US FDA UDI)

by Datascope Corp.

Identity

Trade Name
Ochsner Small Pediatric ECC Pack FDA UDI
Generic Name
Cardiopulmonary bypass system blood tubing set FDA UDI
Device Name
Softshell Venous Reser 800 ml Blood Transfer Bag 1000mL CDi Sat Cel l1/4 Gas Filter FDA UDI
Model / Reference
BEQ-T 51505 FDA UDI
Description
Softshell Venous Reser 800 ml Blood Transfer Bag 1000mL CDi Sat Cel l1/4 Gas Filter FDA UDI

Identifiers

Catalog Number
709000144 FDA UDI
Primary DI / UDI-DI
00607567208391 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

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

Yes

FDA UDI
Sterilization Method
Ethylene Oxide FDA UDI

Category: Cardiopulmonary bypass system blood tubing set

Ochsner Small Pediatric ECC 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 cb6c1f3f-8577-4848-9413-0a1e7d0fb700 36 fields · synced May 31, 2026