Metrex Research, LLC.

Part Number Lot Number  4511 201008270110

General Hospital and Personal Use Devices

2

No

Worldwide distribution: USA (nationwide) and countries of: Australia, Canada, and Europe.

Pentron Clinical Metrex Research; Pinnacle Cure Sleeve, a protective barrier || The intended use of these devices is to protect both patient and healthcare worker from transfer of microorganisms, body fluids and particulate matter.

CaviCide Lot # 10-1301, 10-2301, 10-2302, 10-2328, 10-2328A, 10-2328B, 10-2331, 10-2333, 10-1334, 10-2334, 10-1335, 10-2335, 10-1342A, 10-1343, 10-2345.  EnviroCide Lot # 10-2331.  Backscratchers Cavicide lot # 10-1342.  MaxiSpray Plus lot # 10-2328A and 10-1343.  pdCARE Surface Disinfectant lot # 10-2331 and 10-2345.  Z3 Surface Disinfectant lot # 10-2328.

General Hospital and Personal Use Devices

1

No

Worldwide Distribution-USA (nationwide) and the countries of Canada, AE, and YE.

CaviCide, Part Numbers: 13-1025, 13-1000, 13-1024, MC-1000. || Alternate brands: || EnviroCide, part number: 13-3325. || Private labeled products of Cavicide: || Backscratchers Cavicide, part number: 13-4800. || MaxiSpray Plus, part numbers: 13-7400 and 13-7405. || pdCARE Surface Disinfectant, part numbers: 13-7525 and 13-7500. || Z3 Surface Disinfectant, part number: 13-7900. || CaviCide is a multi-purpose disinfectant/decontaminant cleaner for use on hard, non-porous inanimate surfaces. CaviCide is a bactericidal, virucidal, fungicidal, and tuberulocidal which is available in a ready-to-use, liquid form typically contained in 1 gallon bottles, 2.5 gallon bottles, 25 oz. spray bottles, or 55 gallon drums (depending on the item number). CaviCide may also be branded as a private label (see (1)(vi) below for names and Table 1 above for additional details). The product may be used (1) for precleaning non-instrument surfaces prior to disinfection; (2) for precleaning instruments prior to disinfection; (3) as a virucide on non-instrument surfaces; (4) as a disinfectant on non-instrument surfaces; (5) as a virucide on precleaned non-critical medical devices, instruments and implements; and (6) as a disinfectant on precleaned non-critical medical devices, instruments, and instruments. It is useful in health care settings such as hospitals, emergency medical settings, surgical centers, isolation areas, neonatal units, patient care areas, ophthalmic and optometric facilities, dental offices, dental operatories, animal care facilities, salon settings, emergency vehicles, schools, health club facilities, kitchens, bathrooms, prisons, morgues, and other critical care areas.

Lot No. 16-2340PA

General Hospital and Personal Use Devices

1

No

Nationwide Distribution to PA, FL, IL, MN, TX, AL, NY

CaviWipes1 Extra Large, Part No. 13-5150 || The brand name of the device is CaviWipes1 Extra Large, a surface disinfectant. The device has been assigned the product code LRJ (General Purpose Disinfectant) by the FDA and is classified as a Class I Medical Device. CaviWipes1 Extra Large is intended to be used to disinfect surfaces.