Regard™ 315727REG

GUDID 10326053105651

RESOURCE OPTIMIZATION & INNOVATION, L.L.C.

External defibrillator electrode pad

Primary Device ID	10326053105651
NIH Device Record Key	8fb8c64e-ba5e-4e25-90da-93474e221517
Commercial Distribution Status	In Commercial Distribution
Brand Name	Regard™
Version Model Number	PED-100
Catalog Number	315727REG
Company DUNS	945020902
Company Name	RESOURCE OPTIMIZATION & INNOVATION, L.L.C.
Device Count	1
DM Exempt	false
Pre-market Exempt	true
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Operating and Storage Conditions

Storage Environment Temperature	Between -20 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00326053105654 [Primary]
GS1	10326053105651 [Package] Contains: 00326053105654 Package: [10 Units] In Commercial Distribution

FDA Product Code

LDD	Dc-Defibrillator, Low-Energy, (Including Paddles)
MLN	Electrode, Electrocardiograph, Multi-Function

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	2
Public Version Date	2018-03-29
Device Publish Date	2017-03-24

On-Brand Devices [Regard™]

10326053105736	T100-CS
10326053105699	PEDIATRIC-PHILIPS
10326053105682	PEDIATRIC-PHYSIO
10326053105668	PEDIATRIC-ZOLL
10326053105651	PED-100
10326053105514	T100AC-PHILIPS
10326053105507	T100AC-PHYSIO
10326053105491	T100AC-ZOLL
10326053105484	T100AC
20326053116050	SP1051
20326053114360	GS0982
20326053108710	GS0439
10326053106108	C100LOAC-PHYSIO
10326053106092	C100LOAC-PHILIPS
10326053106085	C100LOAC-ZOLL
10326053106078	C100LOAC
10326053106061	T100LOAC-PHYSIO
10326053106054	T100LOAC-PHILIPS
10326053106047	T100LOAC-ZOLL
10326053106030	T100LOAC
10326053106023	C100AC-PHILIPS
10326053106016	C100AC-PHYSIO
10326053106009	C100AC-ZOLL
20326053114926	AN1026
20326053108826	GS0751
20326053100967	OR0095
20326053116159	GY1058
20326053114117	CV0965
20326053108482	HT0333
20326053103548	OB0166
20326053101001	EY0099
20326053108284	GS0441
20326053113776	GY0941
20326053112656	GS0810
20326053100479	LD0108
20326053116630	OR1083
20326053112045	GS0264
20326053115336	AN1041
20326053113899	NU0909
20326053110720	LD0399
20326053100233	LD0025
20326053109397	EY0266
20326053116708	OR1078
20326053116692	OR1077
20326053113837	LD0928
20326053113578	OR0943
20326053100974	NU0096
20326053100332	GS0037
20326053113110	GS0864
20326053115428	GS1043

Trademark Results [Regard]

Mark Image Registration \| Serial	Company Trademark Application Date
REGARD 97196978 not registered Live/Pending	HealthTensor, Inc. 2021-12-30
REGARD 86179619 4824780 Live/Registered	MPC GROUP LLC 2014-01-30
REGARD 86154589 4680759 Live/Registered	LG Electronics Inc. 2013-12-30
REGARD 85721657 4544205 Live/Registered	Steelcase Inc. 2012-09-06
REGARD 85342365 not registered Dead/Abandoned	Clarke Mosquito Control Products, Inc. 2011-06-09
REGARD 85236797 not registered Dead/Abandoned	M. Z. Berger & Co., Inc. 2011-02-08
REGARD 85025545 not registered Dead/Abandoned	Syngenta Participations AG 2010-04-28
REGARD 79033880 3340362 Dead/Cancelled	Kreon, naamloze vennootschap 2006-12-07
REGARD 78773486 not registered Dead/Abandoned	Frederick Goldman, Inc. 2005-12-14
REGARD 78064405 2675687 Dead/Cancelled	Regard Ventures, LLC 2001-05-18
REGARD 77864510 4289323 Live/Registered	Resource Optimization & Innovation, LLC 2009-11-04
REGARD 75742545 not registered Dead/Abandoned	GARD CORPORATION 1999-10-30