What is FDA product code OFQ?

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 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 Kit

ambIT* Cassette – Filter, Male Luer

Catalogue number 220266, listed by Avanos Medical, Inc., United States, under Anesthesia Kit. 3 manufacturers in China are registered for this product code.

Registry build 21.09.26

3manufacturers in China registered for this device type

1catalogue number

Who Else Makes It

Concentrated in Zhejiang (1), Anhui (1), Jiangsu (1).

Chinese manufacturers registered for FDA product code OFQ
Manufacturer	City	Province	Registered as	Device types
GRI Medical & Electronic Technology Co., Ltd.	Jiaxing	Zhejiang	Contract manufacturer	71
Anhui Medpurest Medical Technology Co., Ltd.	Anqing	Anhui	Manufacturer	46
Changzhou Rongxin Medicine Minimal Invasion Technology Co., Ltd.	Jintan	Jiangsu	Contract manufacturer	10

Record

Regulatory record for ambIT* Cassette – Filter, Male Luer
Listed by	Avanos Medical, Inc., United States
FDA product code	OFQ
Device type	Anesthesia Kit
Device class	Class 2
Regulation	21 CFR 868.5120
Establishment	Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer
Record published	2022-01-17
Record revised	2023-06-22 (version 2)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Supplied sterile	Yes
Single use	Yes
Prescription	Prescription only
Label carries	lot or batch number
Packaging	Case of 2, dsp of 10

Catalogue Numbers

Catalogue numbers for ambIT* Cassette – Filter, Male Luer
Catalogue number	Size	Status
220266		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Cardinal Health	Cardinal Health 200, LLC	2,332
Medline Industries, Inc.	Medline Industries, Inc.	54
ambIT	Summit Medical Products, Inc.	34
ACS	American Contract Systems, Inc.	21
ambIT*	Avanos Medical, Inc.	19
Stradis Healthcare	Stradis Healthcare	11
Stradis	Stradis Healthcare	9
Henry Schein	Henry Schein, Inc.	6
Invenio	GRI-Alleset, Inc.	2
ambIT* Cassette – Filter, Spike	Avanos Medical, Inc.	2
ambIT* Cassette – Filter, Spike with Yellow Striped Tubing	Avanos Medical, Inc.	2
Continuous Regional Anesthesia Kit	Custom Interventional Pain Management	2

Showing 12 of 22. All products under Anesthesia Kit

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.