FDA.reportPublic FDA data

Millennium

Primary DI
00190776150426
Brand
Millennium
Company
AVALIGN TECHNOLOGIES, INC.
Model
5-775300
Device description
Indicator Cards 250
Published
2019-12-19
Public version status
New
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
00190776150426PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776150426001907761504261907761504260190776150426

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(877)289-1096product.questions@avalign.com

Regulatory Flags#

DUNS number
792528510
Device count
1
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
false
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
00190776417895Millennium72-53030126C2026-03-23
00190776417901Millennium72-3280326I2026-03-23
00190776417918Millennium72-235613LH2026-03-23
00190776417925Millennium72-3752532026-03-23
00190776417932Millennium100-S03681TRS2026-03-23
00190776417949Millennium72-235633LH2026-03-23
00190776417956Millennium72-5225532B2026-03-23
00190776417963Millennium72-2407032026-03-23
00190776417970Millennium72-4071222026-03-23
00190776417987Millennium1-2236262026-03-23
00190776417994Millennium1-1281562026-03-23
00190776418007Millennium1-OP3702026-03-23
00190776418014Millennium1-7063104R2026-03-23
00190776418021Millennium72-3160021FSYR2026-03-23
00190776418038Millennium1-8207-92026-03-23
00190776418045Millennium1-161762026-03-23
00190776418052Millennium1-3011172026-03-23
00190776418069Millennium1-4301632026-03-23
00190776418076Millennium72-31578452026-03-23
00190776418267Millennium72-24026202026-03-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810194401008AiraAIRA, LLCJOJ2026-02-10
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