FDA.reportPublic FDA data

ProView Plus

Primary DI
H816MPM35541
Brand
ProView Plus
Company
MicroCare, LLC
Model
PM3554
Catalog number
PM3554-1
Device description
"Self Sealing Sterilization Pouch, 3.5"" x 5.25"""
Published
2022-10-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
KCTSterilization Wrap Containers, Trays, Cassettes & Other Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KCTSterilization Wrap Containers, Trays, Cassettes & Other AccessoriesGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
H816MPM35542PackageHIBCC6In Commercial Distribution
H816PM35541PreviousHIBCC0
H816MPM35541PrimaryHIBCC0
H816MPM35540Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Sterilization packaging, single-useA device, typically in the form of a paper sheet, envelope, bag, wrap, or similar, intended to be used to contain medical devices that are to be sterilized. It is designed to allow sterilization of the enclosed medical device and also to maintain sterility of the device until the packaging is opened for use of the device, or until a predetermined shelf date is expired. This is a single-use device.

Regulatory Flags#

DUNS number
118518186
Device count
200
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
H816EZ128Spec Clean Single Enzymatic DetergentEZ128EZ1282025-10-22
H816MPM10161ProView PlusPM1016PM1016-12022-10-26
H816MPM13181ProView PlusPM1318PM1318-12022-10-26
H816MPM24401ProView PlusPM2440PM2440-12022-10-26
H816MPM27901ProView PlusPM2790PM2790-12022-10-26
H816MPM35901ProView PlusPM3590PM3590-12022-10-26
H816MPM54101ProView PlusPM5410PM5410-12022-10-26
H816GEL121Spec Clean Pre Treatment GelGEL12GEL122025-10-23
H816OP1281OptizymeOP128OP1282025-10-23
H816PSC050Spec Clean Ready to Use DisinfectantPSC050PSC0502025-10-23
H816PSC128Spec Clean Ready to Use DisinfectantPSC128PSC1282025-10-23
H816PSC240Spec Clean Ready to Use DisinfectantPSC240PSC2402025-10-23
H816PSC6032Spec Clean Concentrated DisinfectantPSC6032PSC60322025-10-23
H816EZTAB641Spec Clean Enzymatic TabletsEZTAB64EZTAB642025-10-22
H816PCNF128Spec Clean Instrument Detergent AlkalinePCNF128PCNF1282025-10-22
H816PLC128Spec Clean Concentrated Instrument LubricantPLC128PLC1282025-10-22
H816PLR32Spec Clean Instrument LubricantPLR32PLR322025-10-22
H816PREZ128Spec Clean Dual Enzymatic DetergentPREZ128PREZ1282025-10-22
H816PREZ275Spec Clean Dual Enzymatic DetergentPREZ275PREZ2752025-10-22
H816PREZAW050Spec Clean Quad Enzymatic DetergentPREZAW050PREZAW0502025-10-22

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Primary DI, Brand, Company table
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