FDA.reportPublic FDA data

SPS Medical Supply Co

Primary DI
10732224710744
Brand
SPS Medical Supply Co
Company
SPS Medical Supply Corp.
Model
EMP-1004
Catalog number
EMP-1004
Device description
EMPlus Type 6 270F Steam Emulator
Published
2016-11-15
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JOJIndicator, physical/chemical sterilization process

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JOJIndicator, Physical/Chemical Sterilization ProcessGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K102363000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K102363000SPSMEDICAL EMPLUS 270 F STEAM EMULATOR MODEL EMP-104, EMP-1004Spsmedical Supply Corp.2011-01-27JOJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10732224710744PrimaryGS10
00732224710747Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1073222471074410732224710744
00732224710747007322247107477322247107470732224710747

GMDN Terms#

Term, Definition table
TermDefinition
Chemical/physical sterilization process indicatorA sterilization indicator designed to be placed within a sterilizing chamber, and to respond with a characteristic chemical and/or physical change to one or more of the physical conditions within the chamber, to validate the sterilization process. It may be presented in one of a variety of forms (e.g., tape, test pack, tag). 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
+1(585)359-0167regulatoryaffairs@hu-friedy.com

Regulatory Flags#

DUNS number
194877072
Device count
1000
DM exempt
true
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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Primary DI, Brand, Company table
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