Regard™

Primary DI
20194717116216
Brand
Regard™
Company
ROI CPS, LLC
Model
GS00087P
Device description
LOCAL
Published
2022-10-05
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

Product Codes#

Code, Name table
CodeName
OGDCustom Anesthesia Tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OGDCustom Anesthesia TrayAnesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20194717116216PackageGS14In Commercial Distribution
10194717116219PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2019471711621620194717116216
1019471711621910194717116219

GMDN Terms#

Term, Definition table
TermDefinition
Epidural anaesthesia set, non-medicatedA collection of devices intended for the administration of an analgesic or anaesthetic agent (not included) to the epidural space for the management of pain. It includes a needle and/or a catheter with additional procedural devices (e.g., syringe, dressings, guidewire, introducer), and may be intended for single- or continuous-administration. It is not intended for intrathecal anaesthesia This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
117174678
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
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
10194717102298Regard™UR00857C2019-11-21
10194717102304Regard™UR00858B2019-10-28
10194717111733Regard™GS00372E2025-03-30
10194717112488Regard™GS00237H2021-07-19
10194717112990Regard™LD01002CD2021-08-24
10194717113959Regard™GS00310D2021-11-29
10194717113973Regard™GS00311C2021-11-29
10194717114741Regard™PL00126ST2022-02-17
10194717115144Regard™HT00253H2022-03-23
10194717115175Regard™CV00256LM2022-03-23
10194717115830Regard™PL00126T2022-04-28
10194717116028Regard™ET00701GH2022-06-28
10194717116066Regard™HT00253I2022-07-14
10194717121305Regard™GS01065D2025-01-21
20194717102295Regard™UR00857C2019-11-21
10194717100355Regard™UR00279I2019-10-28
10194717100812Regard™UR00847B2019-11-14
10194717104797Regard™UR00739I2019-11-07
10194717104834Regard™UR00746G2019-10-28
10194717106609Regard™UR00746H2019-12-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10194717116219Regard™ROI CPS, LLCOGD2022-10-05
10194717115106Regard™ROI CPS, LLCOGD2022-03-22
10194717113881Regard™ROI CPS, LLCOGD2021-11-19
10195594417451CARDINAL HEALTHCardinal Health 200, LLCOGD2021-11-05
10193489361940Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OGD2021-08-27
10194717112761Regard™ROI CPS, LLCOGD2021-07-28
10194717110590Regard™ROI CPS, LLCOGD2021-05-10
10194717109730Regard™ROI CPS, LLCOGD2021-02-15
10194717109372Regard™ROI CPS, LLCOGD2021-01-14
10194717108924RegardROI CPS, LLCOGD2020-12-10
10194717107675Regard™ROI CPS, LLCOGD2020-06-25
10194717106982Regard™ROI CPS, LLCOGD2020-01-23
10194717101222Regard™ROI CPS, LLCOGD2019-12-23
10194717103042Regard™ROI CPS, LLCOGD2019-12-10
10194717102434Regard™ROI CPS, LLCOGD2019-11-01
10326053117340Regard™Resource Optimization & Innovation, L.L.C.OGD2019-09-18
10326053114363Regard™RESOURCE OPTIMIZATION & INNOVATION, L.L.C.OGD2018-03-28
10326053108713Regard™RESOURCE OPTIMIZATION & INNOVATION, L.L.C.OGD2016-12-23
10326053108737Regard™RESOURCE OPTIMIZATION & INNOVATION, L.L.C.OGD2016-12-23
10326053100885Regard™RESOURCE OPTIMIZATION & INNOVATION, L.L.C.OGD2016-12-21
10326053108317Regard™RESOURCE OPTIMIZATION & INNOVATION, L.L.C.OGD2016-12-20
10326053107129Regard™RESOURCE OPTIMIZATION & INNOVATION, L.L.C.OGD2016-12-05
10809160109212AVID TruCustomAVID MEDICAL, INC.OGD2016-10-11
10809160108284AVID TruCustomAVID MEDICAL, INC.OGD2016-10-04
10809160108031AVID TruCustomAVID MEDICAL, INC.OGD2016-10-03
10809160107317AVID TruCustomAVID MEDICAL, INC.OGD2016-09-28
10809160106143AVID TruCustomAVID MEDICAL, INC.OGD2016-09-20
10809160105177AVID TruCustomAVID MEDICAL, INC.OGD2016-09-19
10809160088395AVID TruCustomAVID MEDICAL, INC.OGD2016-09-15
10809160088708AVID TruCustomAVID MEDICAL, INC.OGD2016-09-15