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.

ACS · Anesthesia Kit → Anesthesiology

Name: ACS
Brand: ACS

3manufacturers in China registered for this device type

21catalogue numbers in this listing

1recall

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 ACS
Listed by	American Contract Systems, Inc.
FDA product code	OFQ
Device type	Anesthesia Kit
Device class	Class 2
Regulation	21 CFR 868.5120
Premarket notification	Exempt
Record published	2020-09-03
Record revised	2022-06-17 (version 4)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Sterilisation	Ethylene Oxide
Supplied sterile	Yes
Single use	Yes
Supplied as a kit	Yes
Label carries	lot or batch number, serial number

Catalogue Numbers

Catalogue numbers for ACS
Catalogue number	Size	Status
UIAN43I		In distribution
MPAO11D		In distribution
UIAN43L		In distribution
UIAN43M		In distribution
MPCK02E		In distribution
LMHA01R		In distribution
BHAK10G		In distribution
SLAS01C		In distribution
MPKK08A		In distribution
SLDT17K		In distribution
LMHA01S		In distribution
LMHA01X		In distribution
LMHA01V		In distribution
UIAN43N		In distribution
MPCH18A		In distribution
UIAN43H		In distribution
UIAN43J		In distribution
SLDT17J		In distribution
UIAN43K		In distribution
BHAK10I		In distribution
LMHA01W		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
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
ambIT* Military PCA Pump	Avanos Medical, Inc.	1

Showing 12 of 22. All products under Anesthesia Kit

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
2023-11-29	Class II	Process control	During an internal investigation, ACS identified that several components were “piggybacked” to ACS trays and subjected to the ACS sterilization process. There is no supporting documentation stating the “piggybacked” components were assessed	182 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.

ACS