What is FDA product code PUB?

This product code is the class II exempt counterpart of MQG, and was exempted, subject to the limitations of exemption, under the procedures established by the 21st Century Cures Act. This device type does not require premarket notification (510(k)) to market if it does not exceed the general limitations of exemption found in 21 CFR 884.9 and the specific limitations of exemption as stated in the Physical State field of this product code description.

Obstetrics & Gynecology › MiscellaneousAccessory, Assisted Reproduction, Exempt

K-Systems

Name: K-Systems
Brand: K-Systems

IVF Incubator. Intended to establish a suitable environment for the development of human embryos/blastocysts for the in vitro fertilization (IVF)/assisted reproductive technology (ART)…

Registry build 21.09.26

IVF Incubator. Intended to establish a suitable environment for the development of human embryos/blastocysts for the in vitro fertilization (IVF)/assisted reproductive technology (ART) procedures.

3manufacturers in China registered for this device type

6catalogue numbers in this listing

Who Else Makes It

Concentrated in Hubei (1), Guangdong (1), Sichuan (1).

Chinese manufacturers registered for FDA product code PUB
Manufacturer	City	Province	Registered as	Device types
Wuhan Huchuang Union Technology Co., Ltd.	Wuhan	Hubei	Manufacturer	8
HUA YUE Medical Technology Co., Ltd.	Guangzhou	Guangdong	Manufacturer	7
MVE Cryogenic Biological Equipment (Chengdu) Co., Ltd.	Pidu District Chengdu	Sichuan	Manufacturer	3

Record

Regulatory record for K-Systems
Listed by	Research Instruments Ltd, United Kingdom
FDA product code	PUB
Device type	Accessory, Assisted Reproduction, Exempt
Device class	Class 2
Regulation	21 CFR 884.6120
Establishment	Contract manufacturer, Manufacturer
Premarket notification	Exempt
Record published	2018-01-31
Record revised	2024-02-28 (version 3)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Prescription	Prescription only
Label carries	lot or batch number, expiry date, manufacturing date, serial number
Storage	Storage environment temperature -5 to 30 °C; Special storage condition: Humidity 5%-75% RH Non condensing. Max 1 week at 50C/122F.

Catalogue Numbers

Catalogue numbers for K-Systems
Catalogue number	Size	Status
G185 Standard 120V US Incubator		In distribution
G210 InviCell Standard US Incubator		In distribution
G210 InviCell		In distribution
G185 SensorTech 120V US Incubator		In distribution
G210 InviCell		In distribution
G210 InviCell US Incubator		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
K-Systems	Coopersurgical, Inc.	66
Fortuna	Research Instruments Ltd	28
Mars	Research Instruments Ltd	19
Multi-zone ART Workstation	Esco Medical Technologies, UAB	13
CT37 Incubator	Planer Limited	9
Titan	Research Instruments Ltd	7
Multiroom IVF incubator	Esco Medical Technologies, UAB	6
Hariomed	HUA YUE Medical Technology Co., Ltd.	4
G185	Research Instruments Ltd	4
PHCbi	PHC Corporation	3
BT37	Planer Limited	2
Aire~Lifeline	Lifeaire Systems	2

Showing 12 of 27. All products under Accessory, Assisted Reproduction, Exempt

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.