What is FDA product code PXL?

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 › TherapeuticVenipuncture Kit

CareDx

Name: CareDx
Brand: CareDx

Needle, Vacutainer® Safety-Lok™ Blood Collection Set

Registry build 21.09.26

1manufacturer

1catalogue number

Who Else Makes It

Registered in Zhejiang.

Chinese manufacturers registered for FDA product code PXL
Manufacturer	City	Province	Registered as	Device types
GRI Medical & Electronic Technology Co., Ltd.	Jiaxing	Zhejiang	Contract manufacturer	71

Record

Regulatory record for CareDx
Listed by	CareDx, Inc., United States
FDA product code	PXL
Device type	Venipuncture Kit
Device class	Class 2
Regulation	21 CFR 880.5570
Establishment	Specification developer, Complaint-file establishment, Manufacturer
Premarket notification	Exempt
Record published	2023-07-24

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Single use	Yes
Prescription	Prescription only
Supplied as a kit	Yes
Label carries	lot or batch number, expiry date

Catalogue Numbers

Catalogue numbers for CareDx
Catalogue number	Size	Status
RMT-00011		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Logmet VA Syringe Kit	NAR Medical Depot, 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.