What is FDA product code DWJ?

If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

Cardiovascular › TherapeuticSystem, Thermal Regulating

Pintler Patient Warming System

Name: Pintler Patient Warming System
Brand: Pintler Patient Warming System

The Pintler Patient Warming System applies conductive heat through an operating-room pad to help maintain patient warmth around surgery. A low-voltage resistance heating element within the…

Registry build 21.09.26

The Pintler Patient Warming System applies conductive heat through an operating-room pad to help maintain patient warmth around surgery. A low-voltage resistance heating element within the pad uses DC power supplied by a separate control unit.

The control unit mounts on a standard IV pole. The system is used in hospitals, surgical centers and other designated surgical settings for adult and pediatric patients, with warming selected by clinical personnel according to the facility’s temperature-management protocol.

Listed Item

The Pintler Patient Warming System a thermal regulating reusable operating room pad and a power control unit. The operating room pad utilizes a low voltage heating element and warms patients with conductive warming technology. The system aids in the function of assisting in maintaining patient warming during perioperative experience for pediatric and adult patients and would be indicated for use in any condition where patient warming is desired

Patient and Procedure Scope

The stated pediatric population begins at 5 kg, and adult use is limited by the table’s weight-bearing capacity. The unit is turned off when prescribed treatment or facility procedure requires hypothermia.

8manufacturers in China registered for this device type

1catalogue number

1510(k) clearance

1recall

Who Else Makes It

Concentrated in Jiangsu (3), Shanghai (1), Anhui (1). 5 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code DWJ
Manufacturer	City	Province	Registered as	Device types
Sino Protection (Hefei) Medical Products Co., Ltd.	Hefei	Anhui	Contract manufacturer	18
Jiangyin Sinbon Electronics Co Ltd	Jiangyin	Jiangsu	Contract manufacturer	13
Copious Intl., Inc.	Heyuan, Guangdong Province		Contract manufacturer	11
Jiangyin Puremed	Jiangyin	Jiangsu	Contract manufacturer	7
Betacera Inc.	Suzhou	Jiangsu	Contract manufacturer	3
Shanghai Xodus Medical Company Limited	Shanghai	Shanghai	Specification developer	25
Hangzhou Tappa Medical Technology Co., Ltd.	Hangzhou	Zhejiang	Manufacturer	3
Jiangmen Dacheng Medical Equipment Co., Ltd.	Jiangmen	Guangdong	Contract manufacturer	1

Record

Regulatory record for Pintler Patient Warming System
Listed by	Pintler Medical, United States
FDA product code	DWJ
Device type	System, Thermal Regulating
Device class	Class 2
Regulation	21 CFR 870.5900
510(k)	K113705
Record published	2019-02-11
Record revised	2023-12-18 (version 2)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Prescription	Prescription only
Latex	Labelled latex-free
Label carries	manufacturing date, serial number

Catalogue Numbers

Catalogue numbers for Pintler Patient Warming System
Catalogue number	Size	Status
PPWS001		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Mistral-Air	The Surgical Company International B.V.	114
Bair Hugger™	3M Company	99
IOB	Jiangmen Dacheng Medical Equipment Co., Ltd.	68
IOB	Iob Medical, Inc.	61
3M™ Bair Hugger™	3M Company	61
Cocoon	Care Essentials PTY Ltd	59
Soft Air	Adroit Medical Systems, Inc.	56
Level 1	ICU Medical, Inc	49
System, Thermal Regulating	Hangzhou Tappa Medical Technology Co., Ltd.	47
PremierPro	Prestige Ameritech	39
Bair Paws™	3M Company	30
SourceMark	Sourcemark, LLC.	25

Showing 12 of 166. All products under System, Thermal Regulating

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K113705	2012-08-31

Recalls Naming This Product

1 recall names this product by its own identifier, the 510(k) it is cleared under.

Recalls naming the identifiers of Pintler Patient Warming System
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity
Pintler Medical	510(k) number	2018-04-20	Class II	Nonconforming Material/Component	Malfunction warming pad.	24

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.