FDA.reportPublic FDA data

PASSPORT PLUS MAIL-IN SYSTEM

Primary DI
50732224720802
Brand
PASSPORT PLUS MAIL-IN SYSTEM
Company
SPS Medical Supply Corp.
Model
PP-052
Catalog number
PP-052
Device description
Mail-in spore strips for use in monitoring the efficacy of Steam, Chemical Vapor, Dry Heat and EO Gas processes.
Published
2016-11-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MRBIndicator, biological, liquid chemical sterilization process

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MRBIndicator, Biological, Liquid Chemical Sterilization ProcessGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50732224720802PackageGS14In Commercial Distribution
10732224720804PrimaryGS10
00732224720807Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5073222472080250732224720802
1073222472080410732224720804
00732224720807007322247208077322247208070732224720807

GMDN Terms#

Term, Definition table
TermDefinition
Biological sterilization indicatorA sterilization indicator consisting of a standardized, viable population of microorganisms (e.g., bacterial spores known to be resistant to the mode of sterilization being monitored) that will display a change when exposed to an effective sterilization outcome indicating that sterilization parameters have been met. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Controlled room temperature per USP
Storage Environment Temperature20 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-585-359-0130regulatoryaffairs@hu-friedy.com

Regulatory Flags#

DUNS number
194877072
Device count
52
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
true
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10732224710041DRY HEAT INDICATOR STRIPDIS-100DIS-1002016-11-15
10732224710058CHEMICAL VAPOR INDICATORVIS-100VIS-1002016-11-15
10732224710065STEAM INDICATOR LABELSIL-1000SIL-10002016-11-15
10732224710072EO GAS INDICATOR LABELGIL-1000GIL-10002016-11-15
10732224710089DRY HEAT INDICATOR LABELDIL-1000DIL-10002016-11-15
10732224710102DUAL MONITOR STRIPDMS-250DMS-2502016-11-15
10732224710126Patient Record CardPRC-250PRC-2502016-11-15
10732224710140LANTOR CUBE BOWIE DICK TEST PACKLCR-025LCR-0252016-11-15
10732224710294EO GAS INDICATOR STRIPGIS-250GIS-2502016-11-15
10732224710317EO Gas Chemical Indicator StripsGIL-250GIL-2502016-11-15
10732224710348CHEMICAL VAPOR INDICATORVIS-250VIS-2502016-11-15
10732224710362DUAL MONITOR STRIP LAMINATEDDMS-250-LDMS-250-L2016-11-15
10732224710393Sterilization Chemical Indicator LabelsSGL-1000SGL-10002016-11-15
10732224710508STEAMPLUS STERILIZER TEST PACKSTP-025STP-0252016-11-15
10732224710522STEAM INDCTR STRIP LAMINATED LONGSIL-250-LSIL-250-L2016-11-15
10732224710553AIRVIEW BOWIE-DICK TEST PACKSBD-030SBD-0302016-11-15
10732224710775AirView II BOWIE-DICK TEST PACKMBD030MBD0302016-11-15
10732224730179STEAM TAPEST-072ST-0722016-11-15
10732224730186STEAM TAPEST-048ST-0482016-11-15
10732224730193STEAM TAPEST-036ST-0362016-11-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
D773590HT12BMS1Health-Tec Biological Monitoring SystemDental Health Products IncMRB2017-01-24
D773590HT52BMS1Health-Tec Biological Monitoring SystemDental Health Products IncMRB2017-01-24
20612479159086McKessonMCKESSON MEDICAL-SURGICAL INC.MRB2016-12-09
20612479159116McKessonMCKESSON MEDICAL-SURGICAL INC.MRB2016-12-09
20612479186006McKessonMCKESSON MEDICAL-SURGICAL INC.MRB2016-12-09
20612479186020McKessonMCKESSON MEDICAL-SURGICAL INC.MRB2016-12-09
00366975003393BENCOBENCO DENTAL SUPPLY CO.MRB2016-11-16
00366975003416BENCOBENCO DENTAL SUPPLY CO.MRB2016-11-16
50732224720017PASSPORT MAIL-IN SYSTEMSPS Medical Supply Corp.MRB2016-11-15
50732224720031PassPort MAIL-IN SYSTEMSPS Medical Supply Corp.MRB2016-11-15
50732224720048PassPort MAIL-IN SYSTEMSPS Medical Supply Corp.MRB2016-11-15
50732224720796PASSPORT PLUS MAIL-IN SYSTEMSPS Medical Supply Corp.MRB2016-11-15