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.

Invenio · Anesthesia Kit → Anesthesiology

Name: Invenio
Brand: Invenio

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 Invenio
Listed by	GRI Medical & Electronic Technology Co., Ltd., China
FDA product code	OFQ
Device type	Anesthesia Kit
Device class	Class 2
Regulation	21 CFR 868.5120
Establishment	Contract manufacturer, Contract steriliser, Specification developer, Manufacturer, Exporter
Premarket notification	Exempt
Record published	2024-02-02
Record revised	2024-09-16 (version 2)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Single use	Yes
Latex	Labelled latex-free
Label carries	lot or batch number
Packaging	Pack of 20

Catalogue Numbers

Catalogue numbers for Invenio
Catalogue number	Size	Status
TUF008		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.

Invenio

Who Else Makes It

Record

Specifications

Catalogue Numbers

Same Product Code

Where China Actually Supplies