Codan

FDA UDI

Class II (US FDA UDI)

by CODAN US Corporation

Identity

Trade Name: CODAN FDA UDI
Generic Name: Blood transfusion set, non-exchange FDA UDI
Device Name: In-Line Burette Set with Needlefree Port FDA UDI
Model / Reference: B 5651 FDA UDI
Description: In-Line Burette Set with Needlefree Port FDA UDI

Identifiers

Primary DI / UDI-DI: 10813153023867 FDA UDI
FDA Product Code: FPA FDA UDI
GMDN Term: Blood transfusion set, non-exchange FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 880.5440 FDA UDI
Commercial Distribution: 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

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

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

FDA UDI

Manufacturing Date

FDA UDI

Category: Blood transfusion set, non-exchange

Codan by CODAN US Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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ICU Medical — ICU MEDICAL, INC. · Class II
ICU Medical — ICU MEDICAL, INC. · Class II
CLEARLINK — BAXTER INTERNATIONAL INC. · Class II

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: CODAN US Corporation

Sources (1)

FDA UDI c48ab2a0-c402-4e0f-9ddf-240a5ccaf6ac 33 fields · synced May 30, 2026