What is FDA product code PXA?

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 › MiscellaneousOral Administration Set

Procedure Pack

Name: Procedure Pack
Brand: Procedure Pack

ZX1000 Mixing Bottle & Dosing Cup + Two Rovipharm 26489151 Oral Dosing Syringes

Registry build 21.09.26

1manufacturer

1catalogue number

Who Else Makes It

Registered in Guangdong.

Chinese manufacturers registered for FDA product code PXA
Manufacturer	City	Province	Registered as	Device types
JWD. Technologies (Jiangmen) Co., Ltd.	Jiangmen	Guangdong	Repacker / relabeller	12

Record

Regulatory record for Procedure Pack
Listed by	Europlaz Technologies Ltd., United Kingdom
FDA product code	PXA
Device type	Oral Administration Set
Device class	Class 1
Regulation	21 CFR 880.6430
Establishment	Contract manufacturer, Repacker / relabeller, Manufacturer
Premarket notification	Exempt
Record published	2026-01-31

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Prescription	Prescription only
Supplied as a kit	Yes
Label carries	lot or batch number, expiry date
Storage	Storage environment temperature 5 to 35 °C
Packaging	Cardboard carton of 4

Catalogue Numbers

Catalogue numbers for Procedure Pack
Catalogue number	Size	Status
ZX2000		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Dosing System	Europlaz Technologies Ltd.	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.