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

Seattle PAP Plus

Name: Seattle PAP plus
Brand: Seattle PAP plus

Catalogue number MP02260, listed by Drägerwerk AG & Co. KGaA, Germany, under Humidifier Nebulizer Kit. 1 manufacturer in China is registered for this product code.

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 Seattle PAP plus
Listed by	Drägerwerk AG & Co. KGaA, Germany
FDA product code	OGG
Device type	Humidifier Nebulizer Kit
Device class	Class 2
Regulation	21 CFR 868.5450
Premarket notification	Exempt
Record published	2019-03-12
Record revised	2023-07-04 (version 3)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Single use	Yes
Label carries	lot or batch number, expiry date, manufacturing date

Catalogue Numbers

Catalogue numbers for Seattle PAP plus
Catalogue number	Size	Status
MP02260		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
Curaplex	Bound Tree Medical, LLC	1

Recalls Naming This Product

1 recall names this product by its own identifier, the UDI on its label.

Recalls naming the identifiers of Seattle PAP plus
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity	Closed
Draeger, Inc.	UDI-DI	2023-04-17	Class I	Process control	Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces.	32,050 untis	2024-09-03

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.