Who else makes this device?

Name: Parker
Brand: Parker

Parker · Tube, Tracheal (W/Wo Connector) → Anesthesiology

9manufacturers in China registered for this device type

157catalogue numbers in this listing

1510(k) clearance

Who Else Makes It

Concentrated in Jiangsu (2), Guangdong (2), Zhejiang (1). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code BTR
Manufacturer	City	Province	Registered as	Device types
Flexicare Medical (Dongguan) Ltd.	Dongguan	Guangdong	Contract manufacturer	48
Well Lead Medical Co., Ltd.	Guangzhou	Guangdong	Contract manufacturer	46
Hangzhou Jinlin Medical Appliances Co., Ltd.	Hangzhou	Zhejiang	Contract manufacturer	11
Jiangxi Yikang Medical Instrument Group Co., Ltd.	Nanchang	Jiangxi	Contract manufacturer	2
Jiangsu NEW Pentastar Medical Products Co., Ltd.	Changzhou	Jiangsu	Exporter	146
Jiangsu Weikang Jiejing Medical Apparatus Co., Ltd.	Shuyang	Jiangsu	Contract manufacturer	18
Qingdao Traworks Co., Ltd.	Qingdao	Shandong	Exporter	7
Tianjin Medis Medical Device Co., Ltd.	Tianjin	Tianjin	Contract manufacturer	5
Chilecom Medical Devices Co Ltd	Xiangtan	Hunan	Manufacturer	5

Record

Regulatory record for Parker
Listed by	Salter Labs, United States
FDA product code	BTR
Device type	Tube, Tracheal (W/Wo Connector)
Device class	Class 2
Regulation	21 CFR 868.5730
Establishment	Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer
510(k)	K984528
Record published	2018-07-20
Record revised	2025-07-02 (version 3)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Supplied sterile	Yes
Single use	Yes
Prescription	Prescription only
Latex	Labelled latex-free
Label carries	lot or batch number, expiry date, manufacturing date
Packaging	Pack of 10, pack of 100, pack of 5, pack of 50, pack of 20
Distribution end date	2025-07-01

Catalogue Numbers

Catalogue numbers for Parker
Catalogue number	Size	Status
H-PFLP-70		In distribution
H-PFOC-90		In distribution
H-PFLP-35		In distribution
H-PTCY-85-90		In distribution
H-PFEC-50		In distribution
H-PFOC-35		In distribution
H-PFOC-40		In distribution
H-PFLP-40		In distribution
H-PFOL-30		In distribution
H-PFOU-45		In distribution
H-PFNU-60		In distribution
H-PFHV-45		In distribution
H-PFRC-55		In distribution
H-PFRC-80		In distribution
H-PFRC-50		In distribution
H-PFUO-80		In distribution
H-PFOC-85		In distribution
H-PFLP-50		In distribution
H-PFUO-70		In distribution
H-PFHV-90		In distribution
H-PFNU-65		In distribution
H-PFNC-80		In distribution
H-PFHV-60		In distribution
H-PFNU-90		In distribution
H-PFOC-30		In distribution
H-PFLP-60		In distribution
H-PFNC-50		In distribution
H-PFHV-50		In distribution
H-PFNC-55		In distribution
H-PFUO-75		In distribution
H-PFHV-80		In distribution
H-PFEC-80		In distribution
H-PFLP-75		In distribution
H-PFST-75		In distribution
H-PFST-80		In distribution
H-PFRU-50		In distribution
H-PFOU-90		In distribution
H-PTCL-60		In distribution
H-PFNC-40		In distribution
H-PTCL-30		In distribution
H-PFLP-30		In distribution
H-PFNU-35		In distribution
H-PFOL-60		In distribution
H-PFLP-85		In distribution
H-PFOC-65		In distribution
H-PTCL-50		In distribution
H-PFST-90		In distribution
H-PFNU-30		In distribution
H-PFLP-90		In distribution
H-PFUO-55		In distribution
H-PFNC-60		In distribution
H-PFOC-45		In distribution
H-PFNC-70		In distribution
H-PTCY-65		In distribution
H-PFUO-65		In distribution
H-PTCL-45		In distribution
H-PFUO-30		In distribution
H-PFOC-50		In distribution
H-PFRC-75		In distribution
H-PFOC-55		In distribution
H-PFOU-85		In distribution
H-PFOC-60		In distribution
H-PFUO-45		In distribution
H-PFOC-75		In distribution
H-PFST-65		In distribution
H-PFST-85		In distribution
H-PFHV-65		In distribution
H-PTCL-35		In distribution
H-PFRC-70		In distribution
H-PFUO-60		In distribution
H-PFST-60		In distribution
H-PFHV-85		In distribution
H-PFEC-70		In distribution
H-PTCY-70		In distribution
H-PFST-50		In distribution
H-PFNU-70		In distribution
H-PFLP-80		In distribution
H-PFOU-60		In distribution
H-PTCY-75		In distribution
H-PMLT-60		In distribution
H-PTCY-60		In distribution
H-PFRC-65		In distribution
H-PFLP-65		In distribution
H-PFST-35		In distribution
H-PFRU-35		In distribution
H-PFUO-95		In distribution
H-PFUO-50		In distribution
H-PFNC-75		In distribution
H-PFRC-95		In distribution
H-PFST-95		In distribution
H-PFHV-70		In distribution
H-PFHV-95		In distribution
H-PFUO-85		In distribution
H-PFNU-45		In distribution
H-PFHV-40		In distribution
H-PMLT-50		In distribution
H-PMLT-40		In distribution
H-PFUO-40		In distribution
H-PFHV-30		In distribution
H-PFNC-65		In distribution
H-PFNU-85		In distribution
H-PFRC-60		In distribution
H-PFST-45		In distribution
H-PFNU-50		In distribution
H-PFRC-85		In distribution
H-PFNU-55		In distribution
H-PFHV-75		In distribution
H-PFUO-20		In distribution
H-PFOU-70		In distribution
H-PFNC-85		In distribution
H-PFHV-55		In distribution
H-PFOU-35		In distribution
H-PFRC-90		In distribution
H-PFLP-95		In distribution
H-PFOC-70		In distribution
H-PFOL-55		In distribution
H-PFNC-90		In distribution
H-PFOL-45		In distribution
H-PFST-40		In distribution
H-PFOU-55		In distribution
H-PFOU-65		In distribution
H-PTCY-80		In distribution
H-PFUO-90		In distribution
H-PFST-55		In distribution
H-PFOU-30		In distribution
H-PFLP-55		In distribution
H-PFST-30		In distribution
H-PFEC-60		In distribution
H-PFST-70		In distribution
H-PFRU-40		In distribution
H-PTCY-85-95		In distribution
H-PFLP-100		In distribution
H-PFUO-35		In distribution
H-PFOC-80		In distribution
H-PFOL-35		In distribution
H-PTCL-25		In distribution
H-PFUO-25		In distribution
H-PFOU-50		In distribution
H-PTCL-70		In distribution
H-PFOL-50		In distribution
H-PTCL-65		In distribution
H-PFOL-40		In distribution
H-PFRU-30		In distribution
H-PFHV-35		In distribution
H-PFNU-40		In distribution
H-PFNC-45		In distribution
H-PTCL-55		In distribution
H-PFOU-75		In distribution
H-PTCY-85		In distribution
H-PFRU-45		In distribution
H-PTCL-40		In distribution
H-PFNU-75		In distribution
H-PFNU-80		In distribution
H-PFHV-100		In distribution
H-PFOU-40		In distribution
H-PFLP-45		In distribution
H-PFOU-80		Withdrawn

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Rusch	Teleflex Medical LLC	301
Shiley	Covidien LP	295
Mallinckrodt	Covidien LP	258
Hudson RCI	Teleflex Medical LLC	241
Portex	ICU Medical, Inc	208
Parker Flex-Tip	Salter Labs	164
Curaplex	Bound Tree Medical, LLC	149
SourceMark	Sourcemark, LLC.	148
Montgomery® Safe-T-Tube™	Boston Medical Products, Inc.	144
Sunmed	SunMed Group Holdings, LLC	112
Forsure	Forsure Medical Products LLC.	101
Sheridan	Teleflex Medical LLC	100

Showing 12 of 374. All products under Tube, Tracheal (W/Wo Connector)

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K190878	2020-01-10

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.

Parker