What is FDA product code PXC?

This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. 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 Medical, LLC. · Personal Protection Kit → General Hospital

Name: Stradis Medical, LLC.
Brand: Stradis Medical, LLC.

8manufacturers in China registered for this device type

2catalogue numbers in this listing

1recall

Who Else Makes It

Concentrated in Guangdong (2), Jiangsu (1), Shandong (1).

Chinese manufacturers registered for FDA product code PXC
Manufacturer	City	Province	Registered as	Device types
Jiangsu NEW Pentastar Medical Products Co., Ltd.	Changzhou	Jiangsu	Exporter	146
Hynaut Health Technology Co., Ltd.	Qingdao	Shandong	Contract manufacturer	68
Hubei Qianjiang Kingphar Medical Material Co., Ltd.	Qianjiang	Hubei	Contract manufacturer	52
Shaoxing Songqiao Textile Co., Ltd.	Shaoxing	Zhejiang	Manufacturer	26
Minlong Pharmaceutical Biotechnology (Shenzhen) Co., Ltd.	Shenzhen	Guangdong	Repacker / relabeller	21
Ming FAI Enterprise International Co., Ltd.	Kowloon	Hong Kong	Exporter	18
Dongguan Luda Industrial Co., Ltd.	Dongguan	Guangdong	Manufacturer	8
Hefei Juniushangmao Co., Ltd.	Hefei	Anhui	Repacker / relabeller	7

Record

Regulatory record for Stradis Medical, LLC.
Listed by	Stradis Healthcare, United States
FDA product code	PXC
Device type	Personal Protection Kit
Device class	Class 1
Regulation	21 CFR 880.6250
Record published	2020-06-05

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Supplied sterile	Yes
Single use	Yes
Supplied as a kit	Yes
Latex	Labelled latex-free
Label carries	lot or batch number, expiry date
Packaging	Outer box of 20

Catalogue Numbers

Catalogue numbers for Stradis Medical, LLC.
Catalogue number	Size	Status
20100SSOP		In distribution
20099SSHP		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Regard™	ROi CPS LLC	19
MedSource Gloves	Medsource International, LLC	7
Bosma Enterprises	Bosma Enterprises	5
Afflink	Bosma Enterprises	4
Stradis Healthcare	Stradis Healthcare	4
NAR	North American Rescue, LLC.	2
McKesson	Mckesson Medical-Surgical Inc.	2
Cardinal Health	Cardinal Health 200, LLC	1
Curaplex	Bound Tree Medical, LLC	1

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
2022-12-15	Class II	Process control	Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit.	21,755 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 Medical, LLC.