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.

Medisana · Chest Drainage Kit → General Hospital

Name: medisana
Brand: medisana

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 medisana
Listed by	Electrical Appliance Branch of Zhangzhou Easepal Industrial Corporation
FDA product code	PAD
Device type	Chest Drainage Kit
Device class	Class 2
Regulation	21 CFR 880.6740
Premarket notification	Exempt
Record published	2024-05-22

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Over the counter	Yes

Catalogue Numbers

Catalogue numbers for medisana
Catalogue number	Size	Status
OL 600		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
Curaplex	Bound Tree Medical, 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.

Medisana

Who Else Makes It

Record

Specifications

Catalogue Numbers

Same Product Code

Where China Actually Supplies