Vital Signs™

Vital Signs™ Anesthesia Circuit Kit, 72" Flexible Dual-Limb, Patient Elbow with Sampling Port, Parallel Wye, In-Line Mini HMEF with Sample Port, Large Adult Mask, M/M GSL 10' X .050ID X…

Registry build 21.09.26

Vital Signs™ Anesthesia Circuit Kit, 72″ Flexible Dual-Limb, Patient Elbow with Sampling Port, Parallel Wye, In-Line Mini HMEF with Sample Port, Large Adult Mask, M/M GSL 10′ X.050ID X.108OD, 3 L Latex-Free Breathing Bag, Disposable

15manufacturers in China registered for this device type
78catalogue numbers in this listing

Who Else Makes It

Concentrated in Jiangsu (6), Guangdong (4), Zhejiang (3). 10 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code CAH
Manufacturer City Province Registered as Device types
Conod Medical Co., Limited Changshu Jiangsu Contract manufacturer 48
Flexicare Medical (Dongguan) Ltd. Dongguan Guangdong Contract manufacturer 48
GaleMed (Xiamen) Co., Ltd. Xiamen Fujian Contract manufacturer 33
Vincent Medical (Dong Guan) Manufacturing Co., Ltd. Dong Guan Guangdong Contract manufacturer 29
Amsino Medical (Shanghai) Co., Ltd. Shanghai Shanghai Contract manufacturer 22
Zhejiang Haisheng Medical Device Co., Ltd. Shaoxing Zhejiang Contract manufacturer 21
Sunmed AP, Ltd. Zhuhai Guangdong Contract manufacturer 18
Sunmed AP, Ltd., Warehouse NO. 2 Zhuhai Guangdong Contract manufacturer 16
Intersurgical Medical Apparatus (Changzhou) Co., Ltd. Changzhou Jiangsu Contract manufacturer 12
GVS Technology (Suzhou) Co., Ltd. Suzhou Jiangsu Contract manufacturer 5
Changshu Rozer Sterilization Technology Co., Ltd. Changshu Jiangsu Contract manufacturer 43
Rozer Sterilization Technology Shuyang Company Limited Shuyang Jiangsu Contract manufacturer 33

Showing 12 of 15. All 15 manufacturers in China registered for Filter, Bacterial, Breathing-Circuit

Record

Regulatory record for Vital Signs™
Listed by SunMed Group Holdings, LLC, United States
FDA product code CAH
Device type Filter, Bacterial, Breathing-Circuit
Device class Class 2
Regulation 21 CFR 868.5260
Establishment Contract manufacturer, Reprocessor, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer
Record published 2025-12-22
Record revised 2026-04-20 (version 3)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Single use Yes
Prescription Prescription only
Supplied as a kit Yes
Latex Labelled latex-free
Label carries lot or batch number, expiry date, manufacturing date
Storage Storage environment temperature -20 to 50 °C
Packaging Box of 20, box of 10, box of 15, box, box of 25

Catalogue Numbers

Catalogue numbers for Vital Signs™
Catalogue number Size Status
9391 In distribution
9809 In distribution
9566 In distribution
9361 In distribution
8244 In distribution
9623 In distribution
9392 In distribution
6888 In distribution
9565 In distribution
9177 In distribution
9335 In distribution
9153A In distribution
9362 In distribution
9677 In distribution
9432 In distribution
9804 In distribution
9810 In distribution
9811 In distribution
9802 In distribution
9663 In distribution
9129 In distribution
9303 In distribution
8569 In distribution
9806 In distribution
9344 In distribution
6887 In distribution
9357 In distribution
9363 In distribution
7-SP5659 In distribution
9053 In distribution
9807 In distribution
7-8113-10-62-68 In distribution
9170 In distribution
9803 In distribution
9421 In distribution
61260T In distribution
9694 In distribution
61272A In distribution
9261 In distribution
9636 In distribution
7-8113-10-67 In distribution
9128 In distribution
9812 In distribution
9808 In distribution
6653 In distribution
9246 In distribution
9247 In distribution
9599 In distribution
5610003 In distribution
5610002 In distribution
51260A-5685 In distribution
9096 In distribution
9342 In distribution
9670 In distribution
9691 In distribution
9665 In distribution
9574 In distribution
6754 In distribution
9575 In distribution
9444 In distribution
9110 In distribution
9106 In distribution
8661 In distribution
9805 In distribution
8624 In distribution
9692 In distribution
9298 In distribution
8624A In distribution
9239 In distribution
9801 In distribution
9061 In distribution
9686 In distribution
8025 In distribution
8809-W In distribution
5610004 In distribution
9169 In distribution
9060 In distribution
9364 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Medline Industries, Inc. Medline Industries, Inc. 405
Pulmoguard S D I Diagnostics Inc 203
Cardinal Health Cardinal Health 200, LLC 131
DAR Covidien LP 110
Portex ICU Medical, Inc 108
Pentair Pentair Filtration Solutions 68
Disposable Anesthesia Circuits Westmed, Inc. 68
AirLife™ AirLife Finland Oy 43
Ventlab Ventlab, LLC 40
VBMax A-M Systems 39
Vital Signs™ AirLife Finland Oy 38
McKesson Mckesson Medical-Surgical Inc. 31

Showing 12 of 545. All products under Filter, Bacterial, Breathing-Circuit

Recalls Naming This Product

1 recall names this product by its own identifier, the UDI on its label.

Recalls naming the identifiers of Vital Signs™
Recalled by Identified by Initiated FDA class Root cause Reason
SunMed Group Holdings, LLC UDI-DI 2023-10-11 Class II Device Design A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing.

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