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)

ABC – Pediatric Compact Breathing Circuit

2 catalogue numbers from PC12123M90000, listed by Engineered Medical Systems, LLC, United States, 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

2catalogue numbers in this listing

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 ABC – Pediatric Compact Breathing Circuit
Listed by	Engineered Medical Systems, LLC, United States
FDA product code	OFP
Device type	Anesthesia Breathing Circuit Kit (Adult & Pediatric)
Device class	Class 1
Regulation	21 CFR 868.5240
Establishment	Contract manufacturer, Manufacturer
Premarket notification	Exempt
Record published	2025-04-11

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Single use	Yes
Label carries	lot or batch number, expiry date
Packaging	Pack of 10

Catalogue Numbers

Catalogue numbers for ABC – Pediatric Compact Breathing Circuit
Catalogue number	Size	Status
PC12123M90000		In distribution
PC12113M0X500		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)

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.