Who else makes this device?

Name: Cool transport container
Brand: Cool transport container

Hematology › Pathology InstrumentationContainer, Specimen Mailer And Storage, Temperature Controlled, Non-Sterile

Cool Transport Container

Catalogue number 95.1123, listed by Sarstedt Aktiengesellschaft & Co.KG, under Container, Specimen Mailer And Storage, Temperature Controlled, Non-Sterile. 4 manufacturers in China are registered for this product code.

Registry build 21.09.26

4manufacturers in China registered for this device type

1catalogue number

Who Else Makes It

Concentrated in Jiangsu (2), Zhejiang (1), Fujian (1).

Chinese manufacturers registered for FDA product code NNL
Manufacturer	City	Province	Registered as	Device types
Boen Healthcare Co., Ltd.	Suzhou	Jiangsu	Specification developer	263
Hospital & Homecare IMP. & EXP. Co., Ltd.	Nanjing	Jiangsu	Contract manufacturer	179
Zhejiang Gongdong Medical Technology Co., Ltd.	Taizhou	Zhejiang	Contract manufacturer	40
International Haotian Technology Co., Ltd.	Xiamen	Fujian	Contract manufacturer	2

Record

Regulatory record for Cool transport container
Listed by	Sarstedt Aktiengesellschaft & Co.KG
FDA product code	NNL
Device type	Container, Specimen Mailer And Storage, Temperature Controlled, Non-Sterile
Device class	Class 1
Regulation	21 CFR 864.3250
Premarket notification	Exempt
Record published	2022-11-30
Record revised	2024-12-11 (version 2)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Label carries	lot or batch number, expiry date
UDI direct marking	Exempt

Catalogue Numbers

Catalogue numbers for Cool transport container
Catalogue number	Size	Status
95.1123		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Mawi DNA Technologies	Mawi DNA Technologies	8
Cardinal Health	Cardinal Health 200, LLC	7
MagBio Genomics, Inc.	Magbio Genomics Inc.	4
ACS Combo-B Incubator	BSL Co., Ltd.	2
Aero-Med	Aero-MED LLC	1
ClinicoLab	Surgyco LLC	1

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.