What is FDA product code PAD?

This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html. This kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market.

General Hospital › MiscellaneousChest Drainage Kit

Curaplex

Name: Curaplex
Brand: Curaplex

*Custom* Curaplex First Flight Chest Tube Kit

Registry build 21.09.26

2manufacturers in China registered for this device type

1catalogue number

Who Else Makes It

All of them in Zhejiang.

Chinese manufacturers registered for FDA product code PAD
Manufacturer	City	Province	Registered as	Device types
GRI Medical & Electronic Technology Co., Ltd.	Jiaxing	Zhejiang	Contract manufacturer	71
Ningbo HLS Medical Products Co., Ltd.	Cixi	Zhejiang	Manufacturer	7

Record

Regulatory record for Curaplex
Listed by	Bound Tree Medical, LLC, United States
FDA product code	PAD
Device type	Chest Drainage Kit
Device class	Class 2
Regulation	21 CFR 880.6740
Establishment	Manufacturer
Premarket notification	Exempt
Record published	2017-09-04
Record revised	2018-03-29 (version 2)

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
UDI direct marking	Exempt

Catalogue Numbers

Catalogue numbers for Curaplex
Catalogue number	Size	Status
8600-01251		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Medline Industries, Inc.	Medline Industries, Inc.	6
medisana	Electrical Appliance Branch of Zhangzhou Easepal Industrial Corporation	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.