What is FDA product code OKU?

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

Obstetrics & Gynecology › SurgicalEmergency Obstetrical Kit

Curaplex

Name: Curaplex
Brand: Curaplex

Curaplex OB Kit, Gloves, Clamps, Scissor, Sponges, Towels, Apron, Tie Off, OB Pad,Underpad,Towelette

Registry build 21.09.26

3manufacturers in China registered for this device type

13catalogue numbers in this listing

Who Else Makes It

All of them in Jiangsu. One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code OKU
Manufacturer	City	Province	Registered as	Device types
Taizhou Xinkang Medical Materials Co., Ltd.	Taizhou	Jiangsu	Contract manufacturer	35
Jiangsu Hanheng Medical Technology Co., Ltd.	Changzhou	Jiangsu	Contract manufacturer	20
Suzhou Dynarex Co., Ltd.	Suzhou	Jiangsu	Contract manufacturer	8

Record

Regulatory record for Curaplex
Listed by	Bound Tree Medical, LLC, United States
FDA product code	OKU
Device type	Emergency Obstetrical Kit
Device class	Class 1
Regulation	21 CFR 884.4520
Establishment	Manufacturer
Premarket notification	Exempt
Record published	2024-07-30
Record revised	2022-08-16 (version 2)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Single use	Yes
Prescription	Prescription only
Supplied as a kit	Yes
Label carries	lot or batch number, expiry date
Packaging	Case of 35, case of 10, case of 40
UDI direct marking	Exempt

Catalogue Numbers

Catalogue numbers for Curaplex
Catalogue number	Size	Status
1460-003QM		In distribution
F1652BAG-A		In distribution
540-1727EA-A		In distribution
J2234-A		In distribution
670227-KIT		In distribution
SOB1APG-23-KIT		In distribution
540-1721EA-A		In distribution
8600-01461		In distribution
1460-004QM		In distribution
1460-002QM		In distribution
44250S		In distribution
SOB1APG-23-KIT		In distribution
8600-01434		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Morrison Medical	Morrison Corporation	16
Cardinal Health	Cardinal Health 200, LLC	7

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.