FDA.reportPublic FDA data

Regard™

Primary DI
10326053104364
Brand
Regard™
Company
RESOURCE OPTIMIZATION & INNOVATION, L.L.C.
Model
243451
Published
2019-10-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
DXQBlood Pressure Cuff

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DXQBlood Pressure CuffCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K080189000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K080189000TEMPA-KUFF SOFT BLOOD PRESSURE CUFF, MODEL 39XXX ; VINYL,MODEL 99XXXTrimline Medical Products Corp.2008-08-15DXQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10326053104364PackageGS120In Commercial Distribution
20326053104361PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1032605310436410326053104364
2032605310436120326053104361

GMDN Terms#

Term, Definition table
TermDefinition
Surgical sponge-counting trayA device in the form of a tray intended to be used in the operating room (OR) to store and maintain the count of surgical sponges/swabs during a surgical procedure, typically to prevent these items from being inadvertently left in a patient. It is a tray with individual sections; it may be weighed following sponge/swab collection to calculate blood loss. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
134472476
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
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
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
00073796318321WIDE-RANGE D-RING CUFFOmron Healthcare, Inc.DXQ2026-07-20
00073796392437SMALL D-RING CUFFOmron Healthcare, Inc.DXQ2026-07-20
06931973438504CaremedShenzhen Caremed Medical Technology Co., Ltd.DXQ2026-07-09
06931973438511CaremedShenzhen Caremed Medical Technology Co., Ltd.DXQ2026-07-09
06931973438528CaremedShenzhen Caremed Medical Technology Co., Ltd.DXQ2026-07-09
06931973454689CaremedShenzhen Caremed Medical Technology Co., Ltd.DXQ2026-07-09
06931973456737CaremedShenzhen Caremed Medical Technology Co., Ltd.DXQ2026-07-09
06931973456744CaremedShenzhen Caremed Medical Technology Co., Ltd.DXQ2026-07-09
06931973456751CaremedShenzhen Caremed Medical Technology Co., Ltd.DXQ2026-07-09
06931973456768CaremedShenzhen Caremed Medical Technology Co., Ltd.DXQ2026-07-09
06931973456775CaremedShenzhen Caremed Medical Technology Co., Ltd.DXQ2026-07-09
06931973456782CaremedShenzhen Caremed Medical Technology Co., Ltd.DXQ2026-07-09
06931973456799CaremedShenzhen Caremed Medical Technology Co., Ltd.DXQ2026-07-09
06931973456805CaremedShenzhen Caremed Medical Technology Co., Ltd.DXQ2026-07-09
06931973456812CaremedShenzhen Caremed Medical Technology Co., Ltd.DXQ2026-07-09
06931973456829CaremedShenzhen Caremed Medical Technology Co., Ltd.DXQ2026-07-09
06931973456836CaremedShenzhen Caremed Medical Technology Co., Ltd.DXQ2026-07-09
06931973456843CaremedShenzhen Caremed Medical Technology Co., Ltd.DXQ2026-07-09
06931973456850CaremedShenzhen Caremed Medical Technology Co., Ltd.DXQ2026-07-09
06931973456867CaremedShenzhen Caremed Medical Technology Co., Ltd.DXQ2026-07-09
06931973456874CaremedShenzhen Caremed Medical Technology Co., Ltd.DXQ2026-07-09
06931973456881CaremedShenzhen Caremed Medical Technology Co., Ltd.DXQ2026-07-09
06931973456898CaremedShenzhen Caremed Medical Technology Co., Ltd.DXQ2026-07-09
06931973456904CaremedShenzhen Caremed Medical Technology Co., Ltd.DXQ2026-07-09
06931973456911CaremedShenzhen Caremed Medical Technology Co., Ltd.DXQ2026-07-09
06931973456928CaremedShenzhen Caremed Medical Technology Co., Ltd.DXQ2026-07-09
06931973456935CaremedShenzhen Caremed Medical Technology Co., Ltd.DXQ2026-07-09
06931973456942CaremedShenzhen Caremed Medical Technology Co., Ltd.DXQ2026-07-09
06931973456959CaremedShenzhen Caremed Medical Technology Co., Ltd.DXQ2026-07-09
06931973456966CaremedShenzhen Caremed Medical Technology Co., Ltd.DXQ2026-07-09