What is FDA product code OGG?

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 kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market.

Anesthesiology › TherapeuticHumidifier Nebulizer Kit

Curaplex

Name: Curaplex
Brand: Curaplex

*Custom* HME Port with Elbow, Double Swivel Kit

Registry build 21.09.26

1manufacturer

1catalogue number

Who Else Makes It

Registered in Jiangsu.

Chinese manufacturers registered for FDA product code OGG
Manufacturer	City	Province	Registered as	Device types
Avita (Wujiang) Co., Ltd.	Wujiang	Jiangsu	Contract manufacturer	15

Record

Regulatory record for Curaplex
Listed by	Bound Tree Medical, LLC, United States
FDA product code	OGG
Device type	Humidifier Nebulizer Kit
Device class	Class 2
Regulation	21 CFR 868.5450
Establishment	Manufacturer
Premarket notification	Exempt
Record published	2016-12-14
Record revised	2018-03-29 (version 2)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Single use	Yes
Prescription	Prescription only
Supplied as a kit	Yes
Latex	Labelled latex-free
Label carries	lot or batch number

Catalogue Numbers

Catalogue numbers for Curaplex
Catalogue number	Size	Status
8600-HMEKIT		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Hudson RCI	Teleflex Medical LLC	156
Hudson RCI	Medline Industries, Inc.	12
AirLife	Carefusion	10
AirLife™	Airlife, Inc.	9
Yirdoc	Qingdao Future Medical Technology Co., Ltd.	4
Medline Industries, Inc.	Medline Industries, Inc.	2
Composite Respiratory Kit	Westmed, Inc.	1
Seattle PAP plus	Drägerwerk AG & Co. KGaA	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.