N/A 78013

by Galemed Corp.

Listed FDA GUDID listing, no authorization on record

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	Number04710810082603 UDI-DI	Date4 Mar 2026Listed	StatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — GUDID listing Listed

Specification

GUDID

Generic Name: Straight/elbow breathing circuit connector, single-use
Model / Ref / Catalog: 78013, AC0225

Primary DI / UDI-DI: 04710810082603
FDA Product Code: BZA
GMDN Term: Straight/elbow breathing circuit connector, single-use

Device Class: Class I
Regulation Number: 868.5810
GUDID distribution status: In Commercial Distribution

Other devices from Galemed Corp.

N/A 5428

Class II
N/A 5429

Class II
N/A AM0002

Class II
N/A AM0001

Class II
N/A AM0003

Class II
N/A 70029

Class I

See all devices from Galemed Corp. →

Properties

Single Use
Prescription Use
Premarket Exempt
Lot / Batch Number
Expiration Date
Manufacturing Date

Other properties (8)

Sterile: No
Implantable: No
Contains Latex: No
Over-the-Counter: No
Convenience Kit: No
Combination Product: No
HCT/P: No
Serial Number: No