FDA.reportPublic FDA data

Hu-Friedy

Primary DI
10889950002718
Brand
Hu-Friedy
Company
HU-FRIEDY MFG. CO., LLC
Model
IMS-1241
Catalog number
IMS-1241
Device description
IMS Integrator Strips (100/Pkg)
Published
2016-09-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
K213412000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K213412000VERIFY STEAM Integrating Indicator, VERIFY STEAM Integrating Indicator 5CMSteris Corparation2022-01-21JOJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10889950002718PrimaryGS10
10889950075019Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088995000271810889950002718
1088995007501910889950075019

GMDN Terms#

Term, Definition table
TermDefinition
Chemical/physical sterilization process indicatorA sterilization indicator designed to respond with a characteristic chemical or physical change to one or more of the physical conditions within the sterilizing chamber. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature60 Degrees Fahrenheit85 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)483-7433info@hu-friedy.com

Regulatory Flags#

DUNS number
005085972
Device count
100
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800012410956Hu-FriedySSC-KIT2026-10-20
08800012411038Hu-FriedySSC-URD22026-10-20
08800012411182Hu-FriedySSC-LRD52026-10-20
08800012411199Hu-FriedySSC-LRD62026-10-20
08800012411205Hu-FriedySSC-LRD72026-10-20
08800012411212Hu-FriedySSC-ULE22026-10-20
08800012411229Hu-FriedySSC-ULE32026-10-20
08800012411236Hu-FriedySSC-ULE42026-10-20
08800012411243Hu-FriedySSC-ULE52026-10-20
08800012411250Hu-FriedySSC-ULE62026-10-20
08800012411267Hu-FriedySSC-ULE72026-10-20
08800012411397Hu-FriedySSC-LRE22026-10-20
08800012411403Hu-FriedySSC-LRE32026-10-20
08800012411410Hu-FriedySSC-LRE42026-10-20
08800012410970Hu-FriedySSC-ULD22024-10-14
08800012410987Hu-FriedySSC-ULD32024-10-14
08800012410994Hu-FriedySSC-ULD42024-10-14
08800012411014Hu-FriedySSC-ULD62024-10-14
08800012411021Hu-FriedySSC-ULD72024-10-14
08800012411045Hu-FriedySSC-URD32024-10-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00724995362973VERIFYALBERT BROWNE LIMITEDJOJ2026-07-16
30818087011618Propper Vapor Line IntegratorsPROPPER MANUFACTURING COMPANY, INC.JOJ2026-07-16
00840456206881JMUJMU DENTAL, INCJOJ2026-07-08
00840456206898JMUJMU DENTAL, INCJOJ2026-07-08
00840456206928JMUJMU DENTAL, INCJOJ2026-07-08
00840456201053JMUJMU DENTAL, INCJOJ2026-06-05
00840456201060JMUJMU DENTAL, INCJOJ2026-06-05
00840456201077JMUJMU DENTAL, INCJOJ2026-06-05
00840456201275JMUJMU DENTAL, INCJOJ2026-06-05
00840456201282JMUJMU DENTAL, INCJOJ2026-06-05
00840456201299JMUJMU DENTAL, INCJOJ2026-06-05
00840456201305JMUJMU DENTAL, INCJOJ2026-06-05
00840456201312JMUJMU DENTAL, INCJOJ2026-06-05
00840456201831JMUJMU DENTAL, INCJOJ2026-06-05
00840456201848JMUJMU DENTAL, INCJOJ2026-06-05
00840456201855JMUJMU DENTAL, INCJOJ2026-06-05
00840456201862JMUJMU DENTAL, INCJOJ2026-06-05
00840456201879JMUJMU DENTAL, INCJOJ2026-06-05
00840456201886JMUJMU DENTAL, INCJOJ2026-06-05
00840456201893JMUJMU DENTAL, INCJOJ2026-06-05
00840456201909JMUJMU DENTAL, INCJOJ2026-06-05
00840456201916JMUJMU DENTAL, INCJOJ2026-06-05
00840456201923JMUJMU DENTAL, INCJOJ2026-06-05
00840456201930JMUJMU DENTAL, INCJOJ2026-06-05
00840456201947JMUJMU DENTAL, INCJOJ2026-06-05
00840456202951JMUJMU DENTAL, INCJOJ2026-06-05
00840456202968JMUJMU DENTAL, INCJOJ2026-06-05
00840456202975JMUJMU DENTAL, INCJOJ2026-06-05
00840456202982JMUJMU DENTAL, INCJOJ2026-06-05
00840456202999JMUJMU DENTAL, INCJOJ2026-06-05