What is FDA product code PYG?

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 › SurgicalSuction Catheter Kit

Curaplex

Name: Curaplex
Brand: Curaplex

Curaplex AirQ3 Kit Size 5 with Suction Catheter (size 18) and Lube Jelly

Registry build 21.09.26

1manufacturer

1catalogue number

Who Else Makes It

Registered in Henan.

Chinese manufacturers registered for FDA product code PYG
Manufacturer	City	Province	Registered as	Device types
Henan Yadu Industrial Co., Ltd.	Changyuan	Henan	Contract manufacturer	35

Record

Regulatory record for Curaplex
Listed by	Bound Tree Medical, LLC, United States
FDA product code	PYG
Device type	Suction Catheter Kit
Device class	Class 1
Regulation	21 CFR 878.4200
Establishment	Manufacturer
Premarket notification	Exempt
Record published	2023-03-30

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 Curaplex
Catalogue number	Size	Status
670261-KIT		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
McKesson	Mckesson Medical-Surgical Inc.	14

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.