Global Healthcare

Endotracheal Tube 6.0MM, UNCUFFED7

Registry build 21.09.26
9manufacturers in China registered for this device type
26catalogue numbers in this listing

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 Global Healthcare
Listed by GHC Healthcare, Inc.
FDA product code BTR
Device type Tube, Tracheal (W/Wo Connector)
Device class Class 2
Regulation 21 CFR 868.5730
510(k) K042683
Record published 2016-09-23
Record revised 2020-08-06 (version 5)

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 Box of 10, case of 10

Catalogue Numbers

Catalogue numbers for Global Healthcare
Catalogue number Size Status
61-185 In distribution
61-045 In distribution
61-145 In distribution
61-060 In distribution
61-065 In distribution
61-020 In distribution
61-055 In distribution
61-140 In distribution
61-080 In distribution
61-030 In distribution
61-190 In distribution
61-150 In distribution
61-135 In distribution
61-180 In distribution
61-050 In distribution
61-025 In distribution
61-160 In distribution
61-075 In distribution
61-170 In distribution
61-155 In distribution
61-175 In distribution
61-035 In distribution
61-130 In distribution
61-040 In distribution
61-070 In distribution
61-165 In distribution

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
Parker Salter Labs 157
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

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

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 Global Healthcare
Recalled by Identified by Initiated FDA class Root cause Reason Quantity
Well Lead Medical Co., Ltd. 510(k) number 2026-07-31 Not classified Process control The 6Fr suction catheter could not pass through the samples smoothly. 27200

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.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer