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

Dr Talbot’s

Catalogue number 78099, listed by Talbot's Pharmaceuticals Family Products LLC, United States, 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 Dr Talbot’s
Listed by	Talbot’s Pharmaceuticals Family Products LLC, United States
FDA product code	PWX
Device type	Insect Sting Emergency Kit
Device class	Class 1
Regulation	21 CFR 880.5740
Establishment	Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer
Premarket notification	Exempt
Record published	2024-08-02

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Over the counter	Yes
Label carries	lot or batch number
Packaging	Pack of 16, pack of 4

Catalogue Numbers

Catalogue numbers for Dr Talbot’s
Catalogue number	Size	Status
78099		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Shubug Pull-It	Shubug, Inc.	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.