What is FDA product code PTN?

This product code is the class II exempt counterpart of DTN, and was exempted, subject to the limitations of exemption, under the procedures established by the 21st Century Cures Act. This device type does not require premarket notification (510(k)) to market if it does not exceed the general limitations of exemption found in 21 CFR 870.9 and the specific limitations of exemption as stated in the Physical State field of this product code description.

Mdhc · Reservoir, Blood, Cardiopulmonary Bypass, Exempt → Cardiovascular

Name: Mdhc
Brand: Mdhc

1manufacturer

1catalogue number

Who Else Makes It

Registered in Guangdong. One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code PTN
Manufacturer	City	Province	Registered as	Device types
Alleva Medical (D.G.) Ltd	Dongguan	Guangdong	Contract manufacturer	13

Record

Regulatory record for Mdhc
Listed by	Mdhc Life Technologies (Kunshan) Co., Ltd.
FDA product code	PTN
Device type	Reservoir, Blood, Cardiopulmonary Bypass, Exempt
Device class	Class 2
Regulation	21 CFR 870.4400
Premarket notification	Exempt
Record published	2023-07-06

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Single use	Yes

Catalogue Numbers

Catalogue numbers for Mdhc
Catalogue number	Size	Status
5 pcs/bag		In distribution

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.

Mdhc

Who Else Makes It

Record

Specifications

Catalogue Numbers

Where China Actually Supplies