SnuggleFit

Interface Cable, SnuggleFit, Abdomen, Alice 6

Registry build 21.09.26
8manufacturers in China registered for this device type
23catalogue numbers in this listing

Who Else Makes It

Concentrated in Guangdong (5), Jiangsu (1), Hebei (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 BZQ
Manufacturer City Province Registered as Device types
Amphenol Medical Technologies (Dongguan) Co., Ltd. Dongguan Guangdong Contract manufacturer 77
Wuhan Strong Electronics Wuhan Hubei Contract manufacturer 6
Ryder Electronics (Shenzhen) Ltd. Shenzhen Guangdong Contract manufacturer 5
Dongguan Smart Manufacturing Partner Electronic Company Limited Dongguan Guangdong Contract manufacturer 1
GE Medical Systems (China) Co., Ltd. Wuxi Jiangsu Contract manufacturer 57
Edan Instruments, Inc. Shenzhen Guangdong Contract manufacturer 56
Contec Medical Systems Co., Ltd. Qinhuangdao Hebei Manufacturer 22
Guangdong Biolight Meditech Co., Ltd. Zhuhai Guangdong Manufacturer 19

Record

Regulatory record for SnuggleFit
Listed by Dymedix Diagnostics Inc, United States
FDA product code BZQ
Device type Monitor, Breathing Frequency
Device class Class 2
Regulation 21 CFR 868.2375
Establishment Specification developer, Manufacturer
510(k) K040605
Record published 2021-07-06

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Single use Yes
Prescription Prescription only
Label carries lot or batch number, manufacturing date
Packaging Pack of 5, pack of 10

Catalogue Numbers

Catalogue numbers for SnuggleFit
Catalogue number Size Status
12-42023-0001 In distribution
18-01811-0001 In distribution
18-01812-0001 In distribution
11-15000-0010 In distribution
12-41115-0001 In distribution
18-13310-0001 In distribution
18-13302-0001 In distribution
18-01814-0001 In distribution
12-42026-0001 In distribution
18-13305-0001 In distribution
12-42024-0001 In distribution
12-42020-0001 In distribution
18-01813-0001 In distribution
12-42025-0001 In distribution
18-01810-0001 In distribution
11-14002-5001 In distribution
18-13300-0001 In distribution
18-13304-0001 In distribution
12-42021-0001 In distribution
18-13301-0001 In distribution
12-42022-0001 In distribution
11-14002-1001 In distribution
12-42027-0001 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Perfect Fit Dymedix Diagnostics Inc 189
Monitor, Breathing Frequency ConMed Corporation 106
Monitor, Breathing Frequency Salter Labs 52
Conmed ConMed Corporation 46
Cadwell Cadwell Industries, Inc. 44
Sensor Respironics Inc. 42
ThermiSense Salter Labs 33
Braebon Cable for Disposable RIP Braebon Medical Corp. 5
PneumoTherm Salter Labs 4
BiNAPS Salter Labs 4
SleepmatePiezo Crystal Sensor & Band, Adult/Ped, Double Buckle, Alice Ambu A/S 4
Braebon PT2 Dual Differntial Airflow Pressure Kit Braebon Medical Corp. 3

Showing 12 of 248. All products under Monitor, Breathing Frequency

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