What is FDA product code PWX?

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.

General Hospital › TherapeuticInsect Sting Emergency Kit

Shubug Pull-It

Name: Shubug Pull-It
Brand: Shubug Pull-It

Catalogue number 503OPULPK1, listed by Shubug, Inc., under Insect Sting Emergency Kit. 1 manufacturer in China is registered for this product code.

Registry build 21.09.26

1manufacturer

1catalogue number

Who Else Makes It

Registered in Zhejiang.

Chinese manufacturers registered for FDA product code PWX
Manufacturer	City	Province	Registered as	Device types
Ningbo Chanson Industry & Trade Co., Ltd.	Ningbo	Zhejiang	Manufacturer	1

Record

Regulatory record for Shubug Pull-It
Listed by	Shubug, Inc.
FDA product code	PWX
Device type	Insect Sting Emergency Kit
Device class	Class 1
Regulation	21 CFR 880.5740
Premarket notification	Exempt
Record published	2026-03-04

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information

Catalogue Numbers

Catalogue numbers for Shubug Pull-It
Catalogue number	Size	Status
503OPULPK1		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Dr Talbot’s	Talbot’s Pharmaceuticals Family Products LLC	1

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.