FDA.reportPublic FDA data

Hu-Friedy

Primary DI
10889950035679
Brand
Hu-Friedy
Company
HU-FRIEDY MFG. CO., LLC
Model
IMCO-INDNA
Catalog number
IMCO-INDNA
Device description
Container Indicator Card NA, 250pcs
Published
2016-09-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
10889950035679PrimaryGS10
10889950074975Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088995003567910889950035679
1088995007497510889950074975

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 Humidity10 Percent (%) Relative Humidity70 Percent (%) Relative Humidity

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
005085972
Device count
250
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
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10889950157326Hu-FriedyIMNO24511C2026-05-26
10889950156008Hu-FriedyIM53FMC22026-03-05
10889950156015Hu-FriedyIM56FMC22026-03-05
10889950155445Hu-FriedyIM4160C4AF2026-02-26
10889950155452Hu-FriedyIM4162C4AF2026-02-26
10889950155469Hu-FriedyIM4163C4AF2026-02-26
10889950155476Hu-FriedyIM4165C4AF2026-02-26
10889950155483Hu-FriedyIM4166C4AF2026-02-26
10889950155490Hu-FriedyIM4168C4AF2026-02-26
10889950155506Hu-FriedyIM4169C4AF2026-02-26
10889950154714Hu-FriedyIM8125E1L2026-02-18
10889950154721Hu-FriedyIM8126E1L2026-02-18
10889950154738Hu-FriedyIM8128E1L2026-02-18
10889950154745Hu-FriedyIM8129E1L2026-02-18
10889950154752Hu-FriedyIM4225LP32026-02-18
10889950154769Hu-FriedyIM4226LP32026-02-18
10889950154776Hu-FriedyIM4228LP32026-02-18
10889950154783Hu-FriedyIM4229LP32026-02-18
10889950154790Hu-FriedyIM4220LP32026-02-18
00889950143285PWR Classic PowderAP-CN2024-09-06

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00810194400896AiraAIRA, LLCJOJ2026-01-16
00810194400933AiraAIRA, LLCJOJ2026-01-16
00810194400964AiraAIRA, LLCJOJ2026-01-16
00810194401022AiraAIRA, LLCJOJ2026-01-16
20705037015921Tyvek®ADVANCED STERILIZATION PRODUCTS SERVICES INC.JOJ2025-12-17
20705037015945Tyvek®ADVANCED STERILIZATION PRODUCTS SERVICES INC.JOJ2025-12-17
20705037015969Tyvek®ADVANCED STERILIZATION PRODUCTS SERVICES INC.JOJ2025-12-17
20705037015914Tyvek®ADVANCED STERILIZATION PRODUCTS SERVICES INC.JOJ2025-12-16
50724995245523Rapicide PA Test StripsMEDIVATORS INC.JOJ2025-06-10
07798375772570VERISURE™TERRAGENE S.A.JOJ2025-06-03
07798375772860SEALSURE™TERRAGENE S.A.JOJ2025-06-03
00850064244045LarrTrue Indicating LLCJOJ2025-04-02
00850064244052CheetaTrue Indicating LLCJOJ2025-04-02
00615375013526MetriCide METREX RESEARCH, LLCJOJ2025-03-21
20686864061162Medicom SafeSealAMD Medicom IncJOJ2025-03-20
00850072625003Arrigo Professional Supplies LLCARRIGO PROFESSIONAL SUPPLIES LLCJOJ2025-03-18
00850072625010Arrigo Professional Supplies LLCARRIGO PROFESSIONAL SUPPLIES LLCJOJ2025-03-18
00850072625034Arrigo Professional Supplies LLCARRIGO PROFESSIONAL SUPPLIES LLCJOJ2025-03-18
00850072625041Arrigo Professional Supplies LLCARRIGO PROFESSIONAL SUPPLIES LLCJOJ2025-03-18
00850072625058Arrigo Professional Supplies LLCARRIGO PROFESSIONAL SUPPLIES LLCJOJ2025-03-18
00860011103424True Indicating Sterilization Indicator TapeTrue Indicating LLCJOJ2025-03-18
00850064244038True IndicatingTrue Indicating LLCJOJ2025-02-27
10724995231504CELERITYSTERIS CORPORATIONJOJ2025-01-13
07798375772532VERISURE™TERRAGENE S.A.JOJ2024-11-13
07798375772754VERISURE™TERRAGENE S.A.JOJ2024-11-13
07798375772808VERISURE™TERRAGENE S.A.JOJ2024-11-13
07798375772846VERISURE™TERRAGENE S.A.JOJ2024-11-12
07798375772907VERISURE™TERRAGENE S.A.JOJ2024-11-12
07798375772969VERISURE™TERRAGENE S.A.JOJ2024-11-12