FDA.reportPublic FDA data

Regard™

Primary DI
10326053118019
Brand
Regard™
Company
RESOURCE OPTIMIZATION & INNOVATION, L.L.C.
Model
PL841
Catalog number
7547360
Device description
Migrating Indicator
Published
2021-08-25
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

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
20326053118016PackageGS120In Commercial Distribution
10326053118019PrimaryGS10
00326053118012Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2032605311801620326053118016
1032605311801910326053118019
00326053118012003260531180123260531180120326053118012

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
Storage Environment Humidity10 Percent (%) Relative Humidity60 Percent (%) Relative Humidity
Storage Environment Temperature10 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
134472476
Device count
250
DM exempt
false
Premarket exempt
true
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
00326053123528Regard™TLPCHCLR-REG2026-03-11
00326053123535Regard™TLPCHSTRP-REG2026-03-11
10326053117692Regard™A3PMSKUL4-REG2021-04-09
10326053117845Regard™A3SRGMSK2-REG2021-04-09
10326053117937Regard™VNYLEXMS3-REGVNYLEXMS3-REG2023-01-11
10326053117944Regard™VNYLEXMM3-REGVNYLEXMM3-REG2023-01-11
10326053117951Regard™VNYLEXML3-REGVNYLEXML3-REG2023-01-11
10326053117968Regard™VNYLEXMXL3-REGVNYLEXMXL3-REG2023-01-11
10326053117999Regard™A3SRGST4X-REG74713002021-04-20
20326053123164Regard™PVP1KIT- REG2025-08-15
10326053118026Regard™361066REG2025-06-10
10326053120777Regard™CVRBTELSXL-REGCVRBTELSXL-REG2025-02-06
10326053120784Regard™CVRBTTIEXL-REGCVRBTTIEXL-REG2025-01-28
20326053121528Regard™DBPCHILD-REG2024-12-02
20326053121535Regard™DBPSMADLT-REG2024-12-02
20326053121542Regard™DBPADLT-REG2024-12-02
20326053121559Regard™DBPADLTL-REG2024-12-02
20326053121566Regard™DBPLRGADLT-REG2024-12-02
20326053121573Regard™DBPLGADLTL-REG2024-12-02
20326053121580Regard™DBPTHIGH-REG2024-12-02

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