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

Mars 1500RE Workstation W/ RI Witness

Name: Mars 1500RE Workstation w/ RI Witness
Brand: Mars 1500RE Workstation w/ RI Witness

Catalogue number WM1500RE-W5120, listed by Coopersurgical, Inc., United States, under Accessory, Assisted Reproduction, Exempt. 3 manufacturers in China are registered for this product code.

Registry build 21.09.26

3manufacturers in China registered for this device type

1catalogue number

1510(k) clearance

6recalls on this code

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 Mars 1500RE Workstation w/ RI Witness
Listed by	Coopersurgical, Inc., United States
FDA product code	PUB
Device type	Accessory, Assisted Reproduction, Exempt
Device class	Class 2
Regulation	21 CFR 884.6120
Establishment	Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer
Record published	2019-02-04
Record revised	2024-02-28 (version 3)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Prescription	Prescription only
Label carries	manufacturing date, serial number

Catalogue Numbers

Catalogue numbers for Mars 1500RE Workstation w/ RI Witness
Catalogue number	Size	Status
WM1500RE-W5120		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
K-Systems	Research Instruments Ltd	6
Hariomed	HUA YUE Medical Technology Co., Ltd.	4
G185	Research Instruments Ltd	4
PHCbi	PHC Corporation	3
BT37	Planer Limited	2

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

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K191020	2020-01-14

Recalls

6 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.

Recalls referencing this product code
Initiated	FDA class	Root cause	Reason	Quantity
2024-11-15	Class II	Process change control	The warming surfaces or incubator well temperatures of the listed products may exceed the desired set temperature. If temperatures exceed the desired set value, the device will alarm appropriately.	43 units
2024-11-15	Class II	Process change control	The warming surfaces or incubator well temperatures of the listed products may exceed the desired set temperature. If temperatures exceed the desired set value, the device will alarm appropriately.	106 units
2024-11-15	Class II	Process change control	The warming surfaces or incubator well temperatures of the listed products may exceed the desired set temperature. If temperatures exceed the desired set value, the device will alarm appropriately.	22 units
2024-11-15	Class II	Process change control	The warming surfaces or incubator well temperatures of the listed products may exceed the desired set temperature. If temperatures exceed the desired set value, the device will alarm appropriately.	35 units
2024-11-15	Class II	Process change control	The warming surfaces or incubator well temperatures of the listed products may exceed the desired set temperature. If temperatures exceed the desired set value, the device will alarm appropriately.	37 units
2024-11-15	Class II	Process change control	The warming surfaces or incubator well temperatures of the listed products may exceed the desired set temperature. If temperatures exceed the desired set value, the device will alarm appropriately.	34 units

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.