FDA.reportPublic FDA data

SPORVIEW SELF-CONTAINED STEAM BI

Primary DI
10732224720934
Brand
SPORVIEW SELF-CONTAINED STEAM BI
Company
SPS Medical Supply Corp.
Model
SCP-050
Catalog number
SCP-050
Device description
In-office biological indicators for use in monitoring the efficacy of steam sterilization processes.
Published
2016-11-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FRCIndicator, biological sterilization process

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRCIndicator, Biological Sterilization ProcessGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K111515000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K111515000SPSMEDICAL SPORVIEW STEAM BISpsmedical Supply Corp.2012-02-01FRC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10732224720934PrimaryGS10
00732224720937Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1073222472093410732224720934
00732224720937007322247209377322247209370732224720937

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)359-0130info@spsmedical.com

Regulatory Flags#

DUNS number
194877072
Device count
50
Lot or batch
true
Expiration date on label
true

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

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