Who else makes this device?

Name: Smart-Well Incubator
Brand: Smart-Well Incubator

General Hospital › MonitoringIndicator, Biological Sterilization Process

Smart-Well Incubator

The Smart-Well Model 1710 EZTest Incubator is intended for use with the Smart-Read EZTest Steam self-contained biological indicator (SCBI). Each incubator cavity has an electronic…

Registry build 21.09.26

The Smart-Well Model 1710 EZTest Incubator is intended for use with the Smart-Read EZTest Steam self-contained biological indicator (SCBI). Each incubator cavity has an electronic monitoring system that detects if the BI is either purple or yellow.

1manufacturer

1catalogue number

3510(k) clearances naming this product code

Who Else Makes It

Registered in Jiangsu. One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code FRC
Manufacturer	City	Province	Registered as	Device types
Sanmina	Kunshan	Jiangsu	Contract manufacturer	15

Record

Regulatory record for Smart-Well Incubator
Listed by	Mesa Laboratories, Inc., United States
FDA product code	FRC
Device type	Indicator, Biological Sterilization Process
Device class	Class 2
Regulation	21 CFR 880.2800
Establishment	Repacker / relabeller, Complaint-file establishment, Manufacturer
510(k)	K122362
Record published	2018-10-16

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Over the counter	Yes
Label carries	serial number

Catalogue Numbers

Catalogue numbers for Smart-Well Incubator
Catalogue number	Size	Status
1710		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Bionova®	Terragene S.A.	47
Attest™	3M Company	36
Verify	Steris Corporation	27
3M™ Attest™	3M Company	16
Celerity	Steris Corporation	15
Biotrace™	Terragene S.A.	11
Single Species BI Strip	Crosstex International	11
Tuttnauer®	Terragene S.A.	10
Sterrad Velocity™	Advanced Sterilization Products Services Inc.	8
GPS	Group Practice Solutions	7
Henry Schein	Henry Schein, Inc.	7
Propper Duo Spore Biological Indicators	Propper Manufacturing Co., Inc.	7

Showing 12 of 173. All products under Indicator, Biological Sterilization Process

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K140589	2014-12-03
K122362	2013-03-26
K112018	2012-01-30

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.