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.

Stradis · Anesthesia Kit → Anesthesiology

Name: Stradis
Brand: Stradis

3manufacturers in China registered for this device type

9catalogue numbers in this listing

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 Stradis
Listed by	Stradis Healthcare, United States
FDA product code	OFQ
Device type	Anesthesia Kit
Device class	Class 2
Regulation	21 CFR 868.5120
Premarket notification	Exempt
Record published	2022-06-22
Record revised	2022-06-17 (version 6)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Supplied sterile	Yes
Single use	Yes
Prescription	Prescription only
Supplied as a kit	Yes
Latex	Labelled latex-free
Label carries	lot or batch number, expiry date, manufacturing date
Distribution end date	2023-01-27

Catalogue Numbers

Catalogue numbers for Stradis
Catalogue number	Size	Status
570-3061		In distribution
682-026NL		In distribution
570-3062		In distribution
570-3063		In distribution
609-012		Withdrawn
570-3132		Withdrawn
690-204		Withdrawn
570-3089		Withdrawn
609-012		Withdrawn

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
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
ambIT* Military PCA Pump	Avanos Medical, Inc.	1

Showing 12 of 22. All products under Anesthesia Kit

Recalls Naming This Product

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

Recalls naming the identifiers of Stradis
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity
Stradis Medical, LLC dba Stradis Healthcare	UDI-DI	2022-11-02	Class II	Packaging process control	Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.	80 units

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.

Stradis