What is FDA product code OFP?

This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. 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.

Anesthesiology › TherapeuticAnesthesia Breathing Circuit Kit (Adult & Pediatric)

Anesthesia Circuit Kit Coax 1

Name: Anesthesia Circuit Kit Coax 1
Brand: Anesthesia Circuit Kit Coax 1

Catalogue number MP02730, listed by Drägerwerk AG & Co. KGaA, Germany, under Anesthesia Breathing Circuit Kit (Adult & Pediatric). 11 manufacturers in China are registered for this product code.

Registry build 21.09.26

11manufacturers in China registered for this device type

1catalogue number

Who Else Makes It

Concentrated in Zhejiang (6), Guangdong (3), Jiangsu (1). One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code OFP
Manufacturer	City	Province	Registered as	Device types
Vincent Medical (Dong Guan) Manufacturing Co., Ltd.	Dong Guan	Guangdong	Contract manufacturer	29
Jiangsu NEW Pentastar Medical Products Co., Ltd.	Changzhou	Jiangsu	Exporter	146
Huzhou Junda Industry Co., Ltd.	Anji	Zhejiang	Contract manufacturer	129
Well Lead Medical Co., Ltd.	Guangzhou	Guangdong	Contract manufacturer	46
Zhejiang Haisheng Medical Device Co., Ltd.	Shaoxing	Zhejiang	Contract manufacturer	21
Ningbo Huakun Medical Equipment Co., Ltd.	Cixi	Zhejiang	Contract manufacturer	19
Shandong Jinlai Huanhai Medical Technology Co., Ltd.	Yantai	Shandong	Manufacturer	19
Hangzhou Shanyou Medical Equipment Co., Ltd.	Hangzhou	Zhejiang	Manufacturer	17
Excellentcare Medical (Huizhou) Ltd.	Huizhou	Guangdong	Manufacturer	14
Shaoxing Reborn Medical Devices Co., Ltd.	Shaoxing	Zhejiang	Manufacturer	14
Ningbo Runmai Medical Technology Co., Ltd.	Cixi	Zhejiang	Repacker / relabeller	7

Record

Regulatory record for Anesthesia Circuit Kit Coax 1
Listed by	Drägerwerk AG & Co. KGaA, Germany
FDA product code	OFP
Device type	Anesthesia Breathing Circuit Kit (Adult & Pediatric)
Device class	Class 1
Regulation	21 CFR 868.5240
Premarket notification	Exempt
Record published	2015-10-24
Record revised	2022-10-24 (version 4)

Specifications

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

Catalogue Numbers

Catalogue numbers for Anesthesia Circuit Kit Coax 1
Catalogue number	Size	Status
MP02730		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
AirLife™	Airlife, Inc.	75
Disposable anesthesia circuits	Westmed, Inc.	73
DeRoyal	Deroyal Industries, Inc.	38
Vital Signs™	Airlife, Inc.	31
Medline Industries, Inc.	Medline Industries, Inc.	30
AirLife™	Vyaire Medical, Inc.	18
Disposable Anesthesia Circuit	Westmed, Inc.	17
Anesthesia Circuit Kit	Westmed, Inc.	11
Simple Solutions Medical	Simple Solutions Medical	10
Vital Signs™	Vyaire Medical, Inc.	8
Vital Signs™	AirLife Finland Oy	8
Uni-Lim Coaxial Circuit	Westmed, Inc.	8

Showing 12 of 129. All products under Anesthesia Breathing Circuit Kit (Adult & Pediatric)

Recalls Naming This Product

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

Recalls naming the identifiers of Anesthesia Circuit Kit Coax 1
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.	200,900 units	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.