Convenience Kit CK003

by InnovaRXI Ltd.

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	Number00628942939754 UDI-DI	Date30 Jan 2025Listed	StatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name: Convenience Kit
Generic Name: General surgical procedure kit, non-medicated, single-use
Model / Reference: CK003
Description: Kit Contents: 1- Pair of Nitrile Examination Gloves 1- Cardiopulmonary Resuscitation (CPR) Mask

Primary DI / UDI-DI: 00628942939754
FDA Product Code: KDD
GMDN Term: General surgical procedure kit, non-medicated, single-use

Device Class: Class I
Regulation Number: 878.4800
GUDID distribution status: In Commercial Distribution

Properties

Single Use
Convenience Kit
Premarket Exempt

Other properties (11)

Sterile: No
Implantable: No
Contains Latex: No
Prescription Use: No
Over-the-Counter: No
Combination Product: No
HCT/P: No
Lot / Batch Number: No
Serial Number: No
Expiration Date: No
Manufacturing Date: No