Vital Signs

Vital Signs™ Flow-inflating tail-end valve transport circuit

Registry build 21.09.26
8manufacturers in China registered for this device type
31catalogue numbers in this listing

Who Else Makes It

Concentrated in Fujian (4), Zhejiang (1), Guangdong (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 BTM
Manufacturer City Province Registered as Device types
Flexicare Medical (Dongguan) Ltd. Dongguan Guangdong Contract manufacturer 48
GaleMed (Xiamen) Co., Ltd. Xiamen Fujian Contract manufacturer 33
Polymed (Xiamen) Plastic Industrial Co., Ltd. Xiamen Fujian Contract manufacturer 17
VR Medical Technology Co., Ltd. Kunshan Jiangsu Contract manufacturer 13
Ambu Limited Xiang Yu F.T.Z., Xiamen Fujian Contract manufacturer 11
Huzhou Junda Industry Co., Ltd. Anji Zhejiang Contract manufacturer 129
Laerdal Medical (Suzhou) Co., Ltd. 215009 Suzhou Jiangsu Province Repacker / relabeller 12
Xiamen Compower Medical Tech. Co., Ltd. Xiamen Fujian Contract manufacturer 9

Record

Regulatory record for Vital Signs
Listed by Carefusion, United States
FDA product code BTM
Device type Ventilator, Emergency, Manual (Resuscitator)
Device class Class 2
Regulation 21 CFR 868.5915
Establishment Specification developer, Manufacturer
Record published 2016-09-22
Record revised 2024-05-21 (version 3)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Single use Yes
Prescription Prescription only
Latex Labelled latex-free
Label carries lot or batch number
Packaging Case of 20
Distribution end date 2022-03-31

Catalogue Numbers

Catalogue numbers for Vital Signs
Catalogue number Size Status
5102RCV1 Withdrawn
5202RADY Withdrawn
5104RDVX Withdrawn
5204RXDV Withdrawn
5101RVX1 Withdrawn
5104RXCV Withdrawn
5129DLV1 Withdrawn
5101RLV1 Withdrawn
5104RVX1 Withdrawn
5124RCXV Withdrawn
5102RLV1 Withdrawn
5126DLV1 Withdrawn
5204RXD2 Withdrawn
5124RDXV Withdrawn
5201RCX2 Withdrawn
5129DV13 Withdrawn
5125DLV1 Withdrawn
5110CVX1 Withdrawn
5204RXCV Withdrawn
5102RV Withdrawn
5102RVX1 Withdrawn
5102RXV Withdrawn
5204CRX1 Withdrawn
5101RCV Withdrawn
5128DLV1 Withdrawn
5102RVW Withdrawn
5201RDX1 Withdrawn
5224RXDV Withdrawn
5204RXC2 Withdrawn
5101RV Withdrawn
5104RCV1 Withdrawn

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Ventlab Ventlab, LLC 405
CPR-2 Bag Mercury Medical Enterprises, LLC 231
CPR Bag Mercury Medical Enterprises, LLC 187
Vital Signs™ Airlife, Inc. 102
Medline Medline Industries, Inc. 78
Spur® II Pediatric ResuscitatorSingle Patient Use Resuscitator Ambu A/S 74
Spur® II Adult ResuscitatorSingle Patient Use Resuscitator Ambu A/S 66
Hudson RCI Teleflex Medical LLC 56
Medline Industries, Inc. Medline Industries, Inc. 53
Portex ICU Medical, Inc 45
Spur® II Infant ResuscitatorSingle Patient Use Resuscitator Ambu A/S 45
Curaplex® Bound Tree Medical, LLC 38

Showing 12 of 342. All products under Ventilator, Emergency, Manual (Resuscitator)

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