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)

Multipac UniFlow Anesthesia Breathing System

Name: Multipac UniFlow anesthesia breathing system
Brand: Multipac UniFlow anesthesia breathing system

Multipac® UniFlow anesthesia breathing system, 1 UniFlow breathing circuit 63 inches long, with end cuffs, 3L latex free reservoir bag and 3m monitoring line

Registry build 21.09.26

11manufacturers in China registered for this device type

1catalogue number

1recall

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 Multipac UniFlow anesthesia breathing system
Listed by	Intersurgical Ltd., United Kingdom
FDA product code	OFP
Device type	Anesthesia Breathing Circuit Kit (Adult & Pediatric)
Device class	Class 1
Regulation	21 CFR 868.5240
Establishment	Specification developer, Complaint-file establishment, Manufacturer, Exporter
Premarket notification	Exempt
Record published	2025-04-11
Record revised	2025-09-08 (version 2)

Specifications

Specifications
MRI safety	MR Safe
Single use	Yes
Prescription	Prescription only
Supplied as a kit	Yes
Label carries	lot or batch number, expiry date, manufacturing date
Packaging	Pack of 8

Catalogue Numbers

Catalogue numbers for Multipac UniFlow anesthesia breathing system
Catalogue number	Size	Status
2900078		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

1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.

Recalls referencing this product code
Initiated	FDA class	Root cause	Reason	Quantity	Closed
2020-11-11	Class II	Process control	The device was assembled with the incorrect exhalation port which can cause gas leakage.	200 devices	2022-08-09

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.