What is FDA product code PUI?

This product code is the class II exempt counterpart of KKX, and was exempted, subject to the limitations of exemption, under the procedures established by the 21st Century Cures Act. This device type does not require premarket notification (510(k)) to market if it does not exceed the general limitations of exemption found in 21 CFR 878.9 and the specific limitations of exemption as stated in the Physical State field of this product code description.

General & Plastic Surgery › SurgicalDrape, Surgical, Exempt

Devon

Name: Devon
Brand: Devon

Devon Magnetic Drape with Stays Neutral Zone 16” x 20” (40.6 cm x 50.8 cm)

Registry build 21.09.26

107manufacturers in China registered for this device type

6catalogue numbers in this listing

10recalls on this code

Who Else Makes It

Concentrated in Jiangsu (28), Guangdong (17), Hubei (14). 43 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code PUI
Manufacturer	City	Province	Registered as	Device types
Allmed Medical Products Co., Ltd.	Zhijiang	Hubei	Contract manufacturer	43
Principle & Will Biotech (Pinghu) Co., Ltd.	Pinghu	Zhejiang	Contract manufacturer	39
BH Medical Products Co., Ltd.	Changzhou	Jiangsu	Contract manufacturer	37
Henan Yadu Industrial Co., Ltd.	Changyuan	Henan	Contract manufacturer	35
Jiangsu JianYu Health Medical Co., Ltd.	Changzhou	Jiangsu	Contract manufacturer	35
Jiangsu Guangda Medical Material Group Co., Ltd.	Haian	Jiangsu	Contract manufacturer	32
Yadu Medical (Henan) Co., Ltd.	Changyuan	Henan	Contract manufacturer	30
Jingmen Huasheng Asia Dynamics Sanitary Products Co., Ltd.	Jingmen	Hubei	Contract manufacturer	23
Suzhou Jinsheng Plastic Co., Ltd.	Suzhou	Jiangsu	Contract manufacturer	23
Sino Protection (Hefei) Medical Products Co., Ltd.	Hefei	Anhui	Contract manufacturer	18
Exact Medical Manufacturing, Inc.	Changzhou	Jiangsu	Contract manufacturer	17
Jiangsu Likang Medical Products Co., Ltd.	Wujiang	Jiangsu	Contract manufacturer	17

Showing 12 of 107. All 107 manufacturers in China registered for Drape, Surgical, Exempt

Record

Regulatory record for Devon
Listed by	Cardinal Health 200, LLC, United States
FDA product code	PUI
Device type	Drape, Surgical, Exempt
Device class	Class 2
Regulation	21 CFR 878.4370
Establishment	Contract manufacturer, Repacker / relabeller, Complaint-file establishment, Manufacturer
Premarket notification	Exempt
Record published	2021-07-12
Record revised	2025-09-01 (version 5)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Single use	Yes
Over the counter	Yes
Label carries	lot or batch number, expiry date
Sizes	Width 16 to 20 in; length 10 to 16 in
Distribution end date	2025-08-31

Catalogue Numbers

Catalogue numbers for Devon
Catalogue number	Size	Per pack	Status
31159612		45	In distribution
31159570		130	Withdrawn
31159588	Width 16 in	130	Withdrawn
31159703		70	Withdrawn
31159679	Length 16 in	65	Withdrawn
31159661		65	Withdrawn

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Convertors	Cardinal Health 200, LLC	1,573
Halyard	O&M Halyard, Inc.	826
Medline-Microtek	Microtek Medical LLC	512
Alleset	GRI Medical & Electronic Technology Co., Ltd.	493
Invenio	GRI Medical & Electronic Technology Co., Ltd.	434
Medline	Medline Industries, Inc.	368
Cardinal Health	Cardinal Health 200, LLC	241
Beaver Visitec Inter	GRI Medical & Electronic Technology Co., Ltd.	179
Steri-Drape™	3M Company	177
Halyard	Owens & Minor Distribution, Inc.	136
Microtek	Microtek Medical LLC	101
Medline Industries, Inc.	Medline Industries, Inc.	87

Showing 12 of 305. All products under Drape, Surgical, Exempt

Recalls

10 of these are 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	Closed
2021-05-21	Class II	Nonconforming Material/Component	The plastic film used to manufacture these Angiography Drape and Cesarean Birth Drape products is causing the drapes to stick, which may prevent the products from being unfolded and applied properly. Sold in single sterile and bulk non-ster	26250 units	2024-01-08
2021-05-21	Class II	Nonconforming Material/Component	The plastic film used to manufacture these Angiography Drape and Cesarean Birth Drape products is causing the drapes to stick, which may prevent the products from being unfolded and applied properly. Sold in single sterile and bulk non-ster	5342 units	2024-01-08
2021-05-21	Class II	Nonconforming Material/Component	The plastic film used to manufacture these Angiography Drape and Cesarean Birth Drape products is causing the drapes to stick, which may prevent the products from being unfolded and applied properly. Sold in single sterile and bulk non-ster	1638 units	2024-01-08
2021-05-21	Class II	Nonconforming Material/Component	The plastic film used to manufacture these Angiography Drape and Cesarean Birth Drape products is causing the drapes to stick, which may prevent the products from being unfolded and applied properly. Sold in single sterile and bulk non-ster	13426 units	2024-01-08
2021-05-21	Class II	Nonconforming Material/Component	The plastic film used to manufacture these Angiography Drape and Cesarean Birth Drape products is causing the drapes to stick, which may prevent the products from being unfolded and applied properly. Sold in single sterile and bulk non-ster	3192 units	2024-01-08
2021-05-21	Class II	Nonconforming Material/Component	The plastic film used to manufacture these Angiography Drape and Cesarean Birth Drape products is causing the drapes to stick, which may prevent the products from being unfolded and applied properly. Sold in single sterile and bulk non-ster	574 units	2024-01-08
2021-05-21	Class II	Nonconforming Material/Component	The plastic film used to manufacture these Angiography Drape and Cesarean Birth Drape products is causing the drapes to stick, which may prevent the products from being unfolded and applied properly. Sold in single sterile and bulk non-ster	15360 units	2024-01-08
2021-05-21	Class II	Nonconforming Material/Component	The plastic film used to manufacture these Angiography Drape and Cesarean Birth Drape products is causing the drapes to stick, which may prevent the products from being unfolded and applied properly. Sold in single sterile and bulk non-ster	6461 units	2024-01-08
2021-02-25	Class II	Nonconforming Material/Component	Cardinal Health has determined that a manufacturing variance in a plastic film used to manufacture these products is causing the drapes and leggings to stick , which may prevent the products from being unfolded and applied properly.	83213 units	2024-01-09
2021-02-25	Class II	Nonconforming Material/Component	Cardinal Health has determined that a manufacturing variance in a plastic film used to manufacture these products is causing the drapes and leggings to stick , which may prevent the products from being unfolded and applied properly.	936 units	2024-01-09

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.