What is FDA product code PYC?

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 & Plastic Surgery › SurgicalParacentesis Tray

Safety Paracentesis Procedure Tray

Name: Safety Paracentesis Procedure Tray
Brand: Safety Paracentesis Procedure Tray

3 catalogue numbers from 00884450277546, listed by Merit Medical Systems, Inc., United States, under Paracentesis Tray. 1 manufacturer in China is registered for this product code.

Registry build 21.09.26

1manufacturer

3catalogue numbers in this listing

1recall

Who Else Makes It

Registered in Jiangsu.

Chinese manufacturers registered for FDA product code PYC
Manufacturer	City	Province	Registered as	Device types
Changzhou CareU Medical Instruments Co., Ltd.	Changzhou	Jiangsu	Manufacturer	9

Record

Regulatory record for Safety Paracentesis Procedure Tray
Listed by	Merit Medical Systems, Inc., United States
FDA product code	PYC
Device type	Paracentesis Tray
Device class	Class 1
Regulation	21 CFR 878.4200
Establishment	Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter
Premarket notification	Exempt
Record published	2018-11-30
Record revised	2025-04-24 (version 4)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Supplied sterile	Yes
Single use	Yes
Prescription	Prescription only
Supplied as a kit	Yes
Label carries	lot or batch number, expiry date
Packaging	Pack of 5

Catalogue Numbers

Catalogue numbers for Safety Paracentesis Procedure Tray
Catalogue number	Size	Status
00884450277546	Catheter French Size (F)-5F	In distribution
00884450277669	Catheter Length-12 cm (4.7″); Catheter French Size (F)-8F; Catheter Length-12 cm (4.7″)	In distribution
00884450277607	Catheter French Size (F)-6F	In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Cardinal Health	Cardinal Health 200, LLC	64
Merit Medical®	Merit Medical Systems, Inc.	1

Recalls

1 of these is Class II. Class II means a temporary or reversible health consequence. 1 is recorded with the root cause “No Marketing Application”: the device was distributed without the premarket submission its class requires, a compliance finding rather than a defect. 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
2024-06-11	Class II	No Marketing Application	Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.	317115 kits

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.