N/A RM21341

by Intersurgical Incorporated

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	Number00619498213412 UDI-DI	Date24 Sep 2016Listed	StatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — GUDID listing Listed

Specification

GUDID

Generic Name: Breathing circuit catheter mount, single-use
Model / Reference: RM21341

Primary DI / UDI-DI: 00619498213412
FDA Product Code: BZA
GMDN Term: Breathing circuit catheter mount, single-use

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

Other devices from Intersurgical Incorporated

See all devices from Intersurgical Incorporated →

Properties

Single Use
Prescription Use
Convenience Kit
Lot / Batch Number
Expiration Date
Manufacturing Date

Other properties (8)

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