enFlow 980121EU

Listed FDA GUDID listing, not in commercial distribution

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number10885403296819 UDI-DI	Date27 Sep 2016Listed	StatusListed GUDID: not in commercial distribution

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name: enFlow
Generic Name: Conduction blood/fluid warmer
Model / Ref / Catalog: 980121EU

Primary DI / UDI-DI: 10885403296819
FDA Product Code: LGZ
GMDN Term: Conduction blood/fluid warmer

Device Class: Class II
Regulation Number: 880.5725
GUDID distribution status: Not in Commercial Distribution

Other devices from Carefusion

BD SmartSite 13mm Vial Access Device; BD SmartSite 20mm Vial Access Device

Class II
Pleurx Pleural Catheter System, Pleurx Catheter Access Kit, Pleurx Catheter Insertion Stylet, Pleurx Integral Valved Pee

Class II
PleurX Peritoneal Catheter System

Class II
End Tidal CO2 Nasal Cannula

Class II
AirLife Infant Heated Wire Circuit Open recall

Class II
BD Secondary Infusion Set

Class II

See all devices from Carefusion →

Properties

Prescription Use
Serial Number
Manufacturing Date

Other properties (11)

Sterile: No
Single Use: No
Implantable: No
Contains Latex: No
Over-the-Counter: No
Convenience Kit: No
Combination Product: No
HCT/P: No
Premarket Exempt: No
Lot / Batch Number: No
Expiration Date: No