Who else makes this device?

Name: Culture Media, 300/BX
Brand: Culture Media, 300/BX

General Hospital › MonitoringIndicator, Biological Sterilization Process

Culture Media, 300/BX

Catalogue number CM-300/300L, listed by Crosstex International, United States, under Indicator, Biological Sterilization Process. 1 manufacturer in China is registered for this product code.

Registry build 21.09.26

1manufacturer

1catalogue number

1510(k) clearance

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 Culture Media, 300/BX
Listed by	Crosstex International, United States
FDA product code	FRC
Device type	Indicator, Biological Sterilization Process
Device class	Class 2
Regulation	21 CFR 880.2800
Establishment	Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer
Record published	2020-03-31

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Single use	Yes
Over the counter	Yes
Label carries	lot or batch number, expiry date
UDI direct marking	Exempt

Catalogue Numbers

Catalogue numbers for Culture Media, 300/BX
Catalogue number	Size	Per pack	Status
CM-300/300L		300	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
K140620	2014-08-07

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.