Who else makes this device?

Name: QFlow 500 Bolt Accessory Kit
Brand: QFlow 500 Bolt Accessory Kit

QFlow 500 Bolt Accessory Kit · Device, Monitoring, Intracranial Pressure → Neurology

5manufacturers in China registered for this device type

1catalogue number

2510(k) clearances naming this product code

Who Else Makes It

Concentrated in Guangdong (3), Shanghai (2). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code GWM
Manufacturer	City	Province	Registered as	Device types
Shanghai Medical Instruments (Group) Ltd. Corp.	Shanghai	Shanghai	Contract manufacturer	235
Amphenol Alden Products Company	Shenzhen	Guangdong	Contract manufacturer	24
PAN-International Precision Electronic Co., Ltd.	Dongguan	Guangdong	Contract manufacturer	4
Shenzhen Mindray BIO-Medical Electronics Co., Ltd.	Shenzhen	Guangdong	Specification developer	61
Shanghai Wilpower Industrial Co., Ltd.	Shanghai	Shanghai	Exporter	33

Record

Regulatory record for QFlow 500 Bolt Accessory Kit
Listed by	Hemedex Incorporated, United States
FDA product code	GWM
Device type	Device, Monitoring, Intracranial Pressure
Device class	Class 2
Regulation	21 CFR 882.1620
Establishment	Manufacturer
510(k)	K141869
Record published	2016-09-23
Record revised	2018-07-06 (version 3)

Specifications

Specifications
MRI safety	MR Unsafe
Sterilisation	Ethylene Oxide
Supplied sterile	Yes
Single use	Yes
Prescription	Prescription only
Supplied as a kit	Yes
Label carries	lot or batch number, expiry date, manufacturing date

Catalogue Numbers

Catalogue numbers for QFlow 500 Bolt Accessory Kit
Catalogue number	Size	Status
NA		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Licox®	GMS, Gesellschaft für medizinische Sondentechnik mbH	38
Sophysa	Sophysa	32
Becker®	Medtronic PS Medical	31
Codman	Cerenovus, Inc.	29
Device, Monitoring, Intracranial Pressure	Medtronic PS Medical	28
Exacta™	Medtronic PS Medical	28
Braincare	Braincare Desenvolvimento E Inovacao Tecnologica SA	24
Camino®	Integra Lifesciences (Ireland) Limited	20
Codman®	Integra LifeSciences Production Corporation	19
Integra®	Integra Lifesciences (Ireland) Limited	17
Aura	Branchpoint & Aura Development LLC	17
Natus	Natus Medical Incorporated	15

Showing 12 of 133. All products under Device, Monitoring, Intracranial Pressure

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K141869	2014-10-10
K032337	2003-10-21

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.

QFlow 500 Bolt Accessory Kit