Who else makes this device?

Name: Teladoc Health, Inc.
Brand: Teladoc Health, Inc.

Teladoc Health, Inc. · System, Test, Blood Glucose, over the Counter → Clinical Chemistry

20manufacturers in China registered for this device type

7catalogue numbers in this listing

Who Else Makes It

Concentrated in Guangdong (8), Jiangsu (4), Zhejiang (4). 8 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code NBW
Manufacturer	City	Province	Registered as	Device types
Acon Biotech (Hangzhou) Co., Ltd.	Hangzhou	Zhejiang	Contract manufacturer	29
Sanmina	Kunshan	Jiangsu	Contract manufacturer	15
Dongguan Honfield Precision Parts Co., Ltd.	Zhangmutou, Dongguan	Guangdong	Contract manufacturer	8
Flextronics Medical Device Manufacturing (Shenzhen) Co., Ltd.	Shenzhen	Guangdong	Contract manufacturer	6
Flextronics Industrial (Shenzhen) Co., Ltd.	Shenzhen	Guangdong	Contract manufacturer	5
Yasee Biomedical Inc	Qingdao	Shandong	Contract manufacturer	5
Altek Medical (kunshan) limited	Kunshan Free Trade Zone	Jiangsu	Contract manufacturer	2
Dongguan Kaifa Technology Co., Ltd.	Dongguan	Guangdong	Contract manufacturer	2
Jiangsu NEW Pentastar Medical Products Co., Ltd.	Changzhou	Jiangsu	Exporter	146
Steris Sterilization Technologies (Suzhou) Ltd	Suzhou	Jiangsu	Contract manufacturer	44
Andon Health Co., Ltd.	Tianjin	Tianjin	Contract manufacturer	22
Vivachek Biotech (Hangzhou) Co., Ltd.	Hangzhou, Zhuji	Zhejiang	Contract manufacturer	21

Showing 12 of 20. All 20 manufacturers in China registered for System, Test, Blood Glucose, Over The Counter

Record

Regulatory record for Teladoc Health, Inc.
Listed by	Teladoc Health, Inc.
FDA product code	NBW
Device type	System, Test, Blood Glucose, Over The Counter
Device class	Class 2
Regulation	21 CFR 862.1345
510(k)	K133584
Record published	2026-02-17

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Over the counter	Yes
Supplied as a kit	Yes
Label carries	lot or batch number, expiry date, serial number
Storage	Handling environment temperature 41 to 113 °F; Handling environment humidity 10 to 90 % RH; Handling environment atmospheric pressure 75 to 101 KiloPascal; Storage environment humidity 10 to 90 % RH

Catalogue Numbers

Catalogue numbers for Teladoc Health, Inc.
Catalogue number	Size	Status
BG500		In distribution
BG500 RD		In distribution
BG300 – DG		In distribution
BG300 WK		In distribution
BG300 RD		In distribution
BG500 WK		In distribution
BG300 – MY		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
True Metrix	Trividia Health, Inc.	40
Fora	Fora Care Inc.	31
True Metrix AIR	Trividia Health, Inc.	21
GE	Bionime Corporation	21
TRUEtrack	Trividia Health, Inc.	17
Medline	Medline Industries, Inc.	15
AgaMatrix	Agamatrix	15
Tenovi	Tenovi Co	13
Auvon	Shenzhen Yuwen E-Commerce Co., Ltd.	11
Accu-Chek Guide	Roche Diagnostics Operations	10
Curaplex	Bound Tree Medical, LLC	10
OneTouch Verio	Lifescan Europe Gmbh	10

Showing 12 of 476. All products under System, Test, Blood Glucose, Over The Counter

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 Teladoc Health, Inc.
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity	Closed
Livongo Health, Inc.	510(k) number	2016-02-18	Class II	Error in labeling	The instructional insert for the In Touch Control Solution for use with the In Touch meter and In Touch strips as a quality control check did not contain the limitation of sensor accuracy: (1) with the use of acetaminophen (Tylenol) (2)	63,000 units	2018-03-06

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.

Teladoc Health, Inc.