FDA.reportPublic FDA data

UNIVERSAL LOAD RECORD CARD CHEMICAL INDICATOR

Primary DI
00732224731537
Brand
UNIVERSAL LOAD RECORD CARD CHEMICAL INDICATOR
Company
SPS Medical Supply Corp.
Model
URC-250
Catalog number
URC-250
Device description
For use in Steam, EO or Hydrogen Peroxide, 3 in x 5 in
Published
2023-08-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10732224731534PrimaryGS10
00732224731537Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1073222473153410732224731534
00732224731537007322247315377322247315370732224731537

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(585)359-0167regulatoryaffairs@hu-friedy.com

Regulatory Flags#

DUNS number
194877072
Device count
250
DM exempt
true
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
false
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

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