HeartSpan®

43 catalogue numbers from 00884450404867, listed by Merit Medical, under Introducer, Catheter. 13 manufacturers in China are registered for this product code.

Registry build 21.09.26
13manufacturers in China registered for this device type
43catalogue numbers in this listing

Who Else Makes It

Concentrated in Jiangsu (5), Beijing (3), Shanghai (2). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code DYB
Manufacturer City Province Registered as Device types
Mehow Innovative (Huizhou) Ltd. Huizhou Guangdong Contract manufacturer 11
Tianjin Demax Medical Technology Co., Ltd. Tianjin Tianjin Contract manufacturer 5
Steris Sterilization Technologies (Suzhou) Ltd Suzhou Jiangsu Contract manufacturer 44
Shanghai INT Medical Instruments Co., Ltd. Shanghai Shanghai Contract manufacturer 10
Lepu Medical Technology (Beijing) Co., Ltd. Beijing Beijing Manufacturer 7
Beijing Target Medical Technologies Inc. Beijing Beijing Contract manufacturer 7
Beijing Demax Medical Technology Co., Ltd. Beijing Beijing Manufacturer 5
Curatia Medical Limited Suzhou Jiangsu Specification developer 5
Tianjin Ethylene Oxide Sterilization Technology Co., Ltd. Tianjin Tianjin Contract manufacturer 4
Shanghai Microport EP Medtech Co., Ltd. Shanghai Shanghai Manufacturer 3
Becton Dickinson Medical Devices Co., Ltd. Suzhou Suzhou Jiangsu Contract manufacturer 2
Cardiocycle Medical(Suzhou) Co., Ltd. Suzhou Jiangsu Complaint-file establishment 1

Showing 12 of 13. All 13 manufacturers in China registered for Introducer, Catheter

Record

Regulatory record for HeartSpan®
Listed by Merit Medical
FDA product code DYB
Device type Introducer, Catheter
Device class Class 2
Regulation 21 CFR 870.1340
Record published 2019-03-07
Record revised 2021-11-08 (version 7)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Supplied sterile Yes
Single use Yes
Supplied as a kit Yes
Label carries lot or batch number, expiry date, manufacturing date
Packaging Pack of 5

Catalogue Numbers

Catalogue numbers for HeartSpan®
Catalogue number Size Status
00884450404867 Sheath French Size-8.5F In distribution
00884450169162 Length (cm)-79.4 cm In distribution
00884450261064 Sheath French Size-8.5F In distribution
00884450404782 Sheath French Size-8.5F In distribution
00884450404836 Sheath French Size-8.5F In distribution
00884450198490 Sheath French Size-8.5F In distribution
00884450286449 Length (cm)-60.0 cm In distribution
00884450169209 Sheath French Size-8.5F In distribution
00884450169186 Sheath French Size-8.5F In distribution
00884450169117 Length (cm)-60.0 cm In distribution
00884450169155 Curve Angle-150°i In distribution
00884450169124 Length (cm)-60.0 cm In distribution
00884450261019 Sheath French Size-8.5F In distribution
00884450260951 Length (cm)-63 cm In distribution
00884450198520 MaxWire Accepted by Dilator (in)-0.038″ In distribution
00884450261002 Length (cm)-63 cm In distribution
00884450404775 Length (cm)-60 cm In distribution
00884450260975 Sheath French Size-8.5F In distribution
00884450261033 Length (cm)-81 cm In distribution
00884450198483 Sheath French Size-8.5F In distribution
00884450261057 Curve Angle-90° In distribution
00884450286456 Sheath French Size-8.5F In distribution
00884450260999 Length (cm)-63 cm In distribution
00884450261071 Length (cm)-81 cm In distribution
00884450404850 Length (cm)-81 cm In distribution
00884450404768 Curve Angle-MP28 In distribution
00884450312797 MaxWire Accepted by Dilator (in)-0.032″ In distribution
00884450260982 Sheath French Size-8.5F In distribution
00884450169070 Length (cm)-60.0 cm In distribution
00884450484517 In distribution
00884450312803 Length (cm) Usable-74 cm In distribution
00884450484524 In distribution
00884450261040 Length (cm)-81 cm In distribution
00884450169193 Length (cm)-79.4 cm In distribution
00884450404751 Length (cm)-61 cm In distribution
00884450260944 Sheath French Size-8.5F In distribution
00884450169148 Length (cm)-60.0 cm In distribution
00884450261026 Curve Angle-135° In distribution
00884450260968 Length (cm)-63 cm In distribution
00884450286210 Curve Angle-30° In distribution
00884450312810 Length (cm) Usable-74 cm In distribution
00884450169131 Sheath French Size-8.5F In distribution
00884450169179 Curve Angle-55° In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Demax Beijing Demax Medical Technology Co., Ltd. 2,841
Arrow Teleflex Medical LLC 1,036
Prelude IDeal™ Merit Medical Systems, Inc. 294
Fast-Cath™ St. Jude Medical 213
Flexor Cook Incorporated 182
Prelude Ease™ Merit Medical Systems, Inc. 176
Performer Cook Incorporated 174
VSI Teleflex Medical LLC 154
Peel-Away Cook Incorporated 153
OptiSeal™ Greatbatch Medical 127
Brilliant Lepu Medical Technology (Beijing) Co., Ltd. 122
Super Sheath Togo Medikit Co., Ltd. 122

Showing 12 of 439. All products under Introducer, Catheter

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