What is FDA product code OKY?

This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.

Obstetrics & Gynecology › SurgicalCytology Kit

Aero-Med

Name: Aero-Med
Brand: Aero-Med

SurePath Cytology Convenience Kit, Health Partners Only

Registry build 21.09.26

1manufacturer

1catalogue number

Who Else Makes It

Registered in Hubei.

Chinese manufacturers registered for FDA product code OKY
Manufacturer	City	Province	Registered as	Device types
Wuhan Landing Intelligence Medical Co., Ltd.	Wuhan	Hubei	Manufacturer	17

Record

Regulatory record for Aero-Med
Listed by	Aero-MED LLC, United States
FDA product code	OKY
Device type	Cytology Kit
Device class	Class 2
Regulation	21 CFR 884.4530
Establishment	Contract manufacturer, Repacker / relabeller, Manufacturer
Premarket notification	Exempt
Record published	2020-01-21
Record revised	2026-04-30 (version 8)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Single use	Yes
Over the counter	Yes
Label carries	lot or batch number, expiry date
Storage	Storage environment temperature 15 to 30 °C
Packaging	Case of 8
Distribution end date	2026-04-30

Catalogue Numbers

Catalogue numbers for Aero-Med
Catalogue number	Size	Status
CA19925		Withdrawn

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Cardinal Health	Cardinal Health 200, LLC	1

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.