FDA.reportPublic FDA data

Regard™

Primary DI
10326053105996
Brand
Regard™
Company
Resource Optimization & Innovation, L.L.C.
Model
C100AC
Catalog number
335559REG
Published
2017-03-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
MLNElectrode, Electrodcardiograph, Multi-Function

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MLNElectrode, Electrocardiograph, Multi-FunctionCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20326053105993PackageGS110In Commercial Distribution
10326053105996PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2032605310599320326053105993
1032605310599610326053105996

GMDN Terms#

Term, Definition table
TermDefinition
External defibrillator electrode padA conductive medium designed to be used between the metal contact surface of an external defibrillator electrode, of the paddle-type, and the patient's skin. A defibrillator electrode pad is available in two basic designs: 1) a thickened conductive gel or polymer layer reinforced by a non-woven material; or 2) a conductive adhesive pad with a metal contact on its outer surface. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-20 Degrees Celsius40 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
134472476
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
20326053123522Regard™TLPCHCLR-REG2026-03-11
20326053123539Regard™TLPCHSTRP-REG2026-03-11
10326053103015Regard™UN 401UN 4012023-08-17
10326053117340Regard™AN10842019-09-18
10326053118071Regard™DSPSCRBSHRTL-REGDSPSCRBSHRTL-REG2023-01-11
10326053118088Regard™DSPSCRBSHRTM-REGDSPSCRBSHRTM-REG2023-01-11
10326053118095Regard™DSPSCRBSHRTXL-REGDSPSCRBSHRTXL-REG2023-01-11
10326053118101Regard™DSPSCRBSHRTXXL-REGDSPSCRBSHRTXXL-REG2023-01-11
10326053118118Regard™DSPSCRBPNTL-REGDSPSCRBPNTL-REG2023-01-11
10326053118125Regard™DSPSCRBPNTM-REGDSPSCRBPNTM-REG2023-01-11
10326053118132Regard™DSPSCRBPNTXL-REGDSPSCRBPNTXL-REG2023-01-11
10326053118149Regard™DSPSCRBPNTXXL-REGDSPSCRBPNTXXL-REG2023-01-11
10326053118156Regard™CHMG38GNSM-REGCHMG38GNSM-REG2023-01-10
10326053118163Regard™CHMG38GNSL-REGCHMG38GNSL-REG2023-01-10
10326053118170Regard™CHMG38GNSXL-REGCHMG38GNSXL-REG2023-01-10
10326053118187Regard™CHMG38GNS2XL-REGCHMG38GNS2XL-REG2023-01-10
10326053118194Regard™CHMG53GNSM-REGCHMG53GNSM-REG2023-01-10
10326053118200Regard™CHMG53GNSL-REGCHMG53GNSL-REG2023-01-11
10326053118217Regard™CHMG53GNSXL-REGCHMG53GNSXL-REG2023-01-11
10326053118224Regard™CHMG53GNS2XL-REGCHMG53GNS2XL-REG2023-01-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00009336010080Heartsync by VermedGRAPHIC CONTROLS ACQUISITION CORPMLN2020-11-06
00009336010097Heartsync by VermedGRAPHIC CONTROLS ACQUISITION CORPMLN2020-11-06
50009336010085Heartsync by VermedGRAPHIC CONTROLS ACQUISITION CORPMLN2020-11-06
50009336010092Heartsync by VermedGRAPHIC CONTROLS ACQUISITION CORPMLN2020-11-06
10888277634893MedlineMEDLINE INDUSTRIES, INC.MLN2020-10-08
10888277634909MedlineMEDLINE INDUSTRIES, INC.MLN2020-10-08
10888277634961MedlineMEDLINE INDUSTRIES, INC.MLN2020-10-08
10888277634985MedlineMEDLINE INDUSTRIES, INC.MLN2020-10-08
10888277634992MedlineMEDLINE INDUSTRIES, INC.MLN2020-10-08
10888277635005MedlineMEDLINE INDUSTRIES, INC.MLN2020-10-08
10888277635012MedlineMEDLINE INDUSTRIES, INC.MLN2020-10-08
10888277635029MedlineMEDLINE INDUSTRIES, INC.MLN2020-10-08
10888277635036MedlineMEDLINE INDUSTRIES, INC.MLN2020-10-08
10888277635050MedlineMEDLINE INDUSTRIES, INC.MLN2020-10-08
10888277635067MedlineMEDLINE INDUSTRIES, INC.MLN2020-10-08
10888277635074MedlineMEDLINE INDUSTRIES, INC.MLN2020-10-08
10888277635081MedlineMEDLINE INDUSTRIES, INC.MLN2020-10-08
10888277635098MedlineMEDLINE INDUSTRIES, INC.MLN2020-10-08
10888277635104MedlineMEDLINE INDUSTRIES, INC.MLN2020-10-08
00326053105456Regard™Resource Optimization & Innovation, L.L.C.MLN2019-10-30
00326053105463Regard™Resource Optimization & Innovation, L.L.C.MLN2019-10-30
00326053105470Regard™Resource Optimization & Innovation, L.L.C.MLN2019-10-30
00326053105555Regard™Resource Optimization & Innovation, L.L.C.MLN2019-10-30
10326053105453Regard™RESOURCE OPTIMIZATION & INNOVATION, L.L.C.MLN2019-10-30
10326053105460Regard™RESOURCE OPTIMIZATION & INNOVATION, L.L.C.MLN2019-10-30
10326053105477Regard™RESOURCE OPTIMIZATION & INNOVATION, L.L.C.MLN2019-10-30
10326053105552Regard™RESOURCE OPTIMIZATION & INNOVATION, L.L.C.MLN2019-10-30
00009336009497Heartsync by VermedGRAPHIC CONTROLS ACQUISITION CORPMLN2019-10-17
00009336009503Heartsync by VermedGRAPHIC CONTROLS ACQUISITION CORPMLN2019-10-17
00009336009510Heartsync by VermedGRAPHIC CONTROLS ACQUISITION CORPMLN2019-10-17